The reported event was inconclusive since the sample cannot be tested.1 sample was confirmed to exhibit the reported failure.It was unknown whether the device had met relevant specifications.The product was used for treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted the balloon was ruptured upon return.The inflation notch was inspected and found to be completely perforated.A potential root cause for this failure could be poor balloon design.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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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.H3 other text : the actual/suspected device was inspected.
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It was reported the balloon of the foley catheter was pierced in the urology department after installation in the operating room.The probe was available for a possible expertise per follow-up information received from ibc on 29oct2021, stated that the balloon was punctured remotely from the robotic radical prostatectomy procedure.The surgeon resuscitated the patient on duty.Per follow-up information received on 16nov2021, it was stated that the there was no resuscitated patient.The surgeon did place another probe.The balloon was punctured and burst distantly from the robotic radical prostatectomy procedure.The surgeon on duty placed another probe in the patient.
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