It was reported that the catheter fell out of the patient due to balloon damage, which occurred on the same day as placement.Per additional information from the ibc via email 06jan2020, the reported event was a balloon burst with no missing pieces.It was unknown how or when the catheter was broken.A second complaint was opened for the broken catheter.
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The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted a sac burst along the lumen.No pieces of the sac were missing.The burst location was observed opposite the inflation eyes.It is unknown what cause could cause the balloon to burst.How and when problem occurred could not determined and could not be classified as a manufacturing related.Potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.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: ¿[contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex." 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.
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It was reported that the catheter fell out of the patient due to balloon damage, which occurred on the same day as placement.Per additional information from the ibc via email 06jan2020, the reported event was a balloon burst with no missing pieces.It was unknown how or when the catheter was broken.
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