The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult catheter insertion was confirmed and the cause was manufacturing-related.The product returned for evaluation was eight 18ga x 10cm powerglide pro midline catheter assemblies.All eight samples were received in their sealed packages.Microscopic inspection samples revealed irregular catheter tips.The catheter tips flared away from the needle shafts.The transition between the catheters and the needles appeared rough.The irregular and outward flaring catheter tips resulted in rough transitions between the introducer needles and the catheters.The catheter tips appeared to have been improperly formed during device manufacture.Photographs have been forwarded to the manufacturing site for further evaluation.A lot history review (lhr) of redz3053 showed seven other similar product complaint(s) from this lot number.
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