C.R. BARD, INC. (BASD) -3006260740 BARD POWERGLIDE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problems
Detachment of Device or Device Component (2907); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2023 |
Event Type
malfunction
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Event Description
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It was reported by the customer "the rn placed the line easily and when she retracted the device, only the wire and the bevel of the needle retracted.The needle was retained in the catheter.Both the catheter and the needle were successfully removed from the patient." no other information was provided.
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Manufacturer Narrative
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The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached powerglide pro needle was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were visible on the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism was engaged over the needle tip.The needle shaft was completely detached from the plastic needle hub.Microscopic inspection of the needle shaft revealed a small amount of clear material near the proximal end.Inspection of the detached needle hub revealed it to appear well-formed.The needle detachment appeared to be caused by adhesive bond failure between the needle shaft and the needle hub.Adhesive may have been improperly applied or cured during device assembly.Photographs have been forwarded to the manufacturing site for further evaluation.
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Event Description
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It was reported by the customer "the rn placed the line easily and when she retracted the device, only the wire and the bevel of the needle retracted.The needle was retained in the catheter.Both the catheter and the needle were successfully removed from the patient." no other information was provided.
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