The following were reviewed as part of this investigation: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hair within a picc kit is inconclusive due to the state of the returned sample.One 5 fr dual lumen powerpicc solo catheter 3cg kit was returned for evaluation.An initial visual observation showed the package the sample was returned in was open.A specimen cup containing a long hair was returned among some of the kit components within the open kit.While a hair was found within the returned sample, the open state of the packaging of the returned sample made it difficult to determine when and where the sample came in contact with the hair.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint of a foreign material within a kit could not be independently confirmed without evaluation of a sealed kit; however, the report of a foreign material within a kit has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
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