The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reax0592 showed no other similar product complaint(s) from this lot number.Device not returned yet.
|
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a rusted tunneler was confirmed, but the exact cause was not determined due to the condition of the returned sample.One open hemostar kit was returned for investigation.The label on the external surface of the package was stained orange.Black smudges were observed on the label.The adhesive dressings were missing from the tray.The 18g introducer needle revealed no discoloration or corrosion on the external surface of the needle cannula.The external surface of the tunneler revealed a reddish orange discoloration.A similar discoloration was observed on sections of the guidewire, which had been partially removed from its hoop.Some of the discolored material was scraped from the tunneler, which revealed pitting in the tunneler.It appears that the kit and components were exposed to high humidity, but it is unknown where or when the humidity was introduced into the tray.Tyvek is not a humidity barrier.Tyvek is a breathable substrate and is designed to allow air/humidity to pass through.The label on the package states, ¿sterilized using ethylene oxide.Do not resterilize.¿ since the package was received open and no breaches in the sterile barrier were observed, the cause was not determined.A lot history review (lhr) of reax0592 showed no other similar product complaint(s) from this lot number.
|