Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
|
It was reported that 6 unspecified bd insyte¿ autoguard¿ catheters' needles got stuck and failed to retract during use.The following information was provided by the initial reporter: "we have noticed a rash of incidences where the bd insyte autoguard winged 20 gauge/1.88 in.Catheter will get stuck and not retract into the plastic housing once deployed.I had over 6 of these happen in one day , then alerted the team, and since, others have experienced the same issue.".
|