"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.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.(b)(4).
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It was reported that up to 22 syringe pmcf had one or more of the following issues before or during use.Scale marking issues (10), plunger rod damaged (5), syringe pump alarms during syringe use (2), drug potency issue (5) the following was reported by the initial reporter: "it was reported via survey response that the clinician encountered drug potency issue, scale marking issue (e.G.Missing/misprinted/blurred scale markings), plunger rod broken/damaged, syringe malfunctioned/caused occlusion alarm while on a pump, difficulty drawing fluid/medication into syringe related to luer lok and luer slip tip syringes.".
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