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 one 18ga x 10cm powerglide midline catheter.Usage residues were observed throughout the sample.The catheter tip appeared to be damaged.Microscopic inspection of the catheter tip confirmed it to be irregular.A small segment appeared to have broken off.The remainder of the catheter tip appeared to flare outward.A non-complainant needle was inserted into the catheter.The transition was rough between the catheter and the needle.The catheter tip damage appeared to be caused by insertion against resistance.It appeared that resistance was caused by a rough transition between the needle and catheter due to an improperly tipped catheter.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to ¿difficult to advance catheter through skin and vein¿ was confirmed.According with the photo evaluation performed at reynosa 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) review is not possible, as no manufacturing lot number has been provided by the complainant.
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