Events

Safety Alert for Monoject Prefill Flush Syringe

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Covidien.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-20
  • Event Date Posted
    2013-08-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130820.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: covidien monoject prefill flush syringe the united states food and drug administration (fda) has posted a press release issued by covidien concerning a voluntary recall of certain lots of monoject prefill flush syringes. the affected products are identified as follow:- monoject 0.9% sodium chloride flush syringe, 12 ml syringe with 10 ml fill product id: 8881570121 lot number: 13a0084n, 13a0094, 13b0364, 13c0504, 13c0514 monoject 0.9% sodium chloride flush syringe, 12 ml syringe with 3 ml fill product id: 8881570123 lot number: 13a0084n monoject 0.9% sodium chloride flush syringe, 12 ml syringe with 5 ml fill product id: 8881570125 lot number: 13a0084n monoject 10 units/ml heparin lock flush, 12 ml syringe with 10 ml fill product id: 8881580121 lot number: 13a0084n monoject 10 units/ml heparin lock flush, 12 ml syringe with 3 ml fill product id: 8881580123 lot number: 13a0084n monoject 10 units/ml heparin lock flush, 12 ml syringe with 5 ml fill product id: 8881580125 lot number: 13a0084n monoject 100 units/ml heparin lock flush, 12 ml syringe with 10 ml fill product id: 8881590121 lot number: 13a0084n monoject 100 units/ml heparin lock flush, 12 ml syringe with 3 ml fill product id: 8881590123 lot number: 13a0084n monoject 100 units/ml heparin lock flush, 12 ml syringe with 5 ml fill product id: 8881590125 lot number: 13a0084n, 13d0824n the recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. these products are labeled as either sodium chloride flush or heparin lock flush. some of these syringes have the mismatched syringe tip cap, syringe label, filled volume and wrapper. however, for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume and wrapper, there are no visual cues for the clinician to identify the problematic products. if non-sterile fluid is administered there is a health risk of life-threatening infection to the blood stream or other areas. besides, if the clinician uses the heparin lock flush syringe containing only water on peripheral or venous catheters, the patency of the intravascular device may not be maintained and clotting may occur. this could result in non-functional intravenous access requiring the device to be replaced the affected users are required to identify, segregate and return any affected products in their inventory. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm365577.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2013.

Device

Monoject Prefill Flush Syringe
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Covidien Monoject Prefill Flush Syringe
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH