Catalog Number 0165L16 |
Device Problems
Deflation Problem (1149); Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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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Event Description
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It was reported that the catheter fell out due to water leakage from the balloon.
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Manufacturer Narrative
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The reported event was unconfirmed since the problem could not be reproduced.The evaluation found no leakage observed even when pressure was applied on the sac.The sample went under a 7 day leak test and no leakage was observed.There was no leakage from the valve.The catheter was dissected and no conditions were found that could have contributed to the reported event.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: ¿(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.".
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Event Description
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It was reported that the catheter fell out due to water leakage from the balloon.
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Search Alerts/Recalls
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