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.Initial reporter phone #: an additional phone # was provided as (b)(6).Device manufacture date: unknown investigation summary: as the material and lot numbers were unknown for this incident and samples were unavailable for return, 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 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 unspecified bd safetyglide syringe experienced 2 cases of leakage, and 1 case of damaged or open unit packaging/seal where sterility was compromised.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 leakage (2), needlestick injury before use on patient (2), syringe needle connectivity issue (3), package open before use (1).Additional information related to what leaked and from where: "saline solution.Intravenous antibiotic." "connection point between the tubing and the needle.".
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