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.Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.Investigation conclusion: no photos or samples were received for evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined.Since no samples displaying the reported condition were received corrective actions are not necessary.
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It was reported that unspecified bd safetyglide syringe experienced 12 cases of clogged/blocked needles, 2 cases of the needle being pulled out of the hub, and 1 case of safety mechanism failure.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via survey response that the clinician experienced needlestick injury after patient use prior to safety mechanism activation (1), needle clogged (12), needle dull/blunt (10), needle pulled out of hub (2).Additional information related to nsi after pt use states: "a blister.".
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