Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).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 unspecified bd¿ catheter tip syringe leaked on 2 occasions, open packaging on 32 occasions, blood exposure on 2 occasions, and damaged stopper on 5 occasions.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 leakage (2), reaction at the injection site (50), open packaging (30) and clinician exposure to blood / bodily fluid (2) related to luer lok and luer slip tip syringes as well as defective / damaged stopper (5) and open packaging (2) related to catheter tip syringes.
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