It was reported tha the unspecified bd¿ iv catheter leaked after it was placed.The following information was provided by the initial reporter: "we had a safecare recently about a defective iv leaking after it was placed.The iv was placed by another staff member and was leaking even after multiple attempts to contain the leak.I changed the dressing, changed the needleless connector, and flushed the line attempting to find the lead.The line was leaking at the base of the insertion site.I took the line out.¿.
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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: 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.Examination of the product involved may provide clarification as to the cause for the reported failure.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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