The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was not used on a patient, but is intended to be used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "improper strain relief material".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is unlikely to be caused by the user.Correction: h.H11: section a through f - the information provided by bd represents all 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 bd.
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