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).Device expiration date: unknown.Device manufacture date: unknown.Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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It was reported that the unspecified bd syringe needle was clogged.The following information was provided by the initial reporter: pca pump alarming occlusion, pt becoming more agitated, no kinks in tubing, got new pump still alarming occluded, agitation increasing, new syringe ordered and primed with new tubing which solved the problem, pt needed additional dosing.
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