The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to insufficient package design that did not protect the product from elements during shipping and storage.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions for use: 1) remove tray lid 2) place under pad beneath patient, plastic side down.3) put on cuffed gloves 4) position drape on patient 5) open lubricant.Lubricate catheter 6) open packet of swabs 7) prep patient with swabs 8) proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water filled syringe gently into valve (do not over penetrate) and depress plunger.Instill entire amount of sterile water.9) to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe stick in the valve.If you notice slow or no deflation reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol the valve arm may be severed.If this fails 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.Warning : after use, the product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product." the device was not returned.
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