Events

Safety Alert for VenaSeal Closure System Model SP-101

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

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
    2015-05-04
  • Event Date Posted
    2015-05-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150504.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: medtronic venaseal closure system model sp-101 medical device manufacturer, medtronic, has issued a medical device safety alert concerning all former sapheon (covidien) venasea closure systems model sp-101. the manufacturer is conducting a voluntary recall of all former sapheon (covidien) venaseal closure systems due to potential for sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray which does not directly affect the sterility of the device components. the manufacturer has received one complaint potentially related to this issue resulting in an occurrence rate of 0.0253%. this complaint is associated with a serious patient injury; however it is unclear if this injury is device related. there have been no reports of death related to this issue. according to the manufacturer, the breach in the pouch barrier may not be detectable by visual inspection of the product. while the device components within the sealed inner tray are not directly affected by this issue, the introduction of a non-sterile inner tray (outer surface of the inner tray contaminated) could potentially contaminate the sterile field and sterile personnel, thereby creating a possible indirect pathway for microbes to come in contact with the patient, which may cause an infection. if a patient has received treatment with a venaseal closure system, no action is required and patients should continue to be monitored in accordance with standard of care. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 may 2015.

Device

VenaSeal Closure System Model SP-101
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic VenaSeal Closure System Model SP-101
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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