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.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future, the complaint will be reopened for further investigation.Unable to perform dhr due to unknown lot number.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
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It was reported that after administering a flu shot with the unspecified bd¿ syringe with needle, the customer's arm "turned into a serious red rash and swelled up", as the customer "had reaction to the nickel".The customer was "informed to take benadryl" by her pharmacist, but there was no medical intervention reported.
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