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 trend investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Root cause description: root cause is undetermined.Rationale: no sample, lot, or batch provided.
|
It was reported that while using the bd needle spinal s/su 25ga 3-1/2in quincke the healthcare provider received a contaminated needle stick.Verbatim: it was reported that a needle stick injury occurred on the clinician after having used the needle on the patient.In this occurrence the clinician recapped the needle after using it, then went to use it again and the needle recoiled and stuck the tech.In this needle stick occurrence, clinician used the needle on the patient, recapped it and were going to use it again when the needle 'recoiled' and stuck the tech.
|