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.Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).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.
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It was reported that 4 unspecified bd¿ syringes had drug potency issues, 10 syringes leaked, 3 syringes had scale markings issues, 3 syringes had damaged barrels/flanges, 5 syringes had damaged plunger rods, 6 syringes had cracked barrels, 2 syringes had issues with blood exposure to the clinician, 1 syringe had foreign matter inside, and 2 syringes had open packaging units.The following information was provided by the initial reporter: "it was reported via survey response that the clinician encountered drug potency issue (4), leakage (8), reaction at the injection site (5), scale marking issue (3), barrel / flange damaged (3), broken / damaged plunger rod (5), cracked barrel (6), packaging difficult to open / tears (6) and clinician exposure to blood / bodily fluid (2) related to luer lok and luer slip tip syringes as well as leakage (2), foreign matter (1) and open packaging (2) related to catheter tip syringes.".
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