H10: h3,h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images found thin blue fibers in the packaging that matched the coloring and thread size of the nylon strap.The batch number of the packaging this was found in was not found.A visual inspection revealed that the package had not been opened, and the seals did not contain any voids or problems.On this package, however, the top film had been sliced through.It is assumed that this occurred in transit to the evaluation center, as a similar slice was noted on the paper covering the package and the exterior zip bag.There was a small blue fiber in the packaging the matched the color and sheen of the nylon strap.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the drawing found that packages must be free of particulates.The complaint was confirmed and the root cause was associated with transport.Factors that could have contributed to the reported event include excess rubbing or jostling in transport, tough shipping and handling, or an impact event.
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