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.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 unspecified bd syringes experienced 1 case of a broken/damaged plunger rod, 3 cases of device damage/deformation while still considered operable, 3 cases of pump alarm activation during use, 2 cases of damaged or open unit packaging/seal where sterility was compromised, and 2 cases of leakage.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via survey response that the clinician encountered drug potency issue (1), reaction at injection site (5), broken / damaged plunger rod (1), cracked barrel (1), syringe malfunctioned / caused occlusion alarm while on a pump (3), open packaging (2) related to luer lok and luer slip tip syringes as well as drug potency issue (1), leakage of dexketoprofen from the plunger (2), stopped defective / deformed (2), packaging difficult to open / tears (1) related to catheter tip syringes.
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