A further clinical review of the event details was completed and a change in the mdr reportability was identified.Manufacturing review: the lot number was provided and the lot device history records were reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Visual inspection: the sample was received in a sealed inner product packaging sleeve.A strand of material was found inside the sealed packaging, near the lower right hand quadrant of the package.The material was further examined under a microscope and it appeared as a dark brown strand of hair.The hair strand was measured and found to be approximately 2.4mm in length.The origins of the hair are unknown.Functional/performance evaluation: no functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is confirmed for a foreign material in the product package, as a strand of hair was found inside the sealed product packaging sleeve.As a strand of hair was found in the sealed product packaging sleeve, the root cause is manufacturing related.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Dilatation catheter preparation: remove catheter from package.Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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