Safety Alert for Accessory Kit AMS 700. Model: 72401850 - Accessory Kit AMS 700. Anvisa Registration n ° 80219980004.

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.

Between April 2014 and August 2014, AMS received 17 complaints for the 5325 devices sold by Keith Needles regarding bending or breaking during use. A review of the history of complaints (August 1, 2012 through July 31, 2013) showed that AMS received a complaint regarding the Keith Needle fold and the complaint regarding the break / component - tool or component / accessory kit break among the 13,708 devices sold. While a preliminary investigation was performed on the observed complaining trend, the supplier noted that the needles associated with 3 batches appeared to not have a fold close to the orifice. This fold is present in the other lots that have been historically supplied by the same supplier. The preliminary AMS investigation indicates that the missing fold may lead to a higher index of folded or broken needles. The supplier decided to recall the 3 batches of Needle Mounts with Fold 84413952.