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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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It was reported that the unspecified bd posiflush¿ syringe had issues with leakage, damaged packaging, inadequate flushing, and stopper separation.The following information was provided by the initial reporter: "it was reported that there was dysgeusia, inadequate flushing, leakage, damaged packaging, patient reaction, and stopper separation from plunger.".
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