Five occurences of this product problem were reported, the details of the other four can be found in: mdr 2245270-2019-00061, mdr 2245270-2019-00062, mdr 2245270-2019-00063, and mdr 2245270-2019-00064.After conducting a thorough investigation, vygon can confirm a quality problem with this product.The cause was a manufacturing error where the product was mis-assembled.This issue occured during a warehouse picking process as some of the wrong catheters were selected for the work order.Based on a review of the remaining component inventory from the same lot, the components were labeled correctly so it can be concluded that this was a human error.This mistake was not caught during the production process.The product's lot history record was reviewed, and several other aspects were missed such as quality sample timing per the associated procedures.The root cause is a manufacturing issue resulting from a combination of human error, failure to follow procedure, and lack of adequate qms processes.This is the first complaint for this product code and issue; however, due to the issue reported and potential harm, a corrective and preventative action (capa) and recall were required.Corrective and preventative actions: vygon usa issued a voluntary recall due to this customer claim.Reference : capa - 00597, recall-2019-01.Update all production and quality work instructions to ensure that these are adequate to prevent re-occurence and are not conflicting.Reference : capa-00597.Implement a better process for sorting/tracking catheter inventory at vygon mfg to avoid picking mix-ups.Reference : capa-00597.
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