The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the catheter cause or contributed to the reported leak was unconfirmed since no leak could be replicated within the device.One 4fr single lumen powerpicc was returned for investigation.The catheter exhibited evidence of use.A suture was tied through the holes in the molded wing and a red colored residue remained on the external surface of the tubing.The catheter had been trimmed to length at the 47cm depth mark.Both a functional test and a microscopic examination revealed no breaches in any part of the catheter.A lot history review (lhr) of recv2105 showed no other similar product complaint(s) from this lot number.
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