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 ten 18ga x 10 cm powerglide pro midline catheter assemblies.All ten 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.(b)(4) evaluation complaint due to ¿catheter is flared out and hard to penetrate the skin¿ was confirmed.According with the photo evaluation performed at (b)(4) facility and gross visual and microscopical visual performed by vad field assurance the following was concluded: the catheter tip was found to be malformed.A rough transition between the needle shaft and the catheter results in the difficulty while attempting to insert through the patient¿s skin.This condition was caused during the catheter tipping process and it makes the device unusable for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of reen2159 showed no other similar product complaint(s) from this lot number.
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