The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due defective component form supplier site and potential root cause for this failure mode could be due defective/torn/broken components.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "bard® silver tsc tray consists of a balloon catheter with temperature-sensing, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, tweezers, waterproof sheet, gauze pads, cotton balls and gloves.There are several types of closed drainage bags.The bag included in the tray will depend on the product." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
|