Model Number 1758SI16 |
Device Problems
Deflation Problem (1149); Leak/Splash (1354); Material Split, Cut or Torn (4008)
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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 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 device was not returned.
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Event Description
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It was reported that the balloon on the foley catheter leaked.The complainant reported that upon further observation, slits were noted in the balloon.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential failure mode could be ¿torn rubberize¿ with a potential root cause of "insufficient latex strength or low/ non uniform rubberize thickness".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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿.
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Event Description
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It was reported that the balloon on the foley catheter leaked.The complainant reported that upon further observation, slits were noted in the balloon.
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Search Alerts/Recalls
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