Catalog Number 0165L18 |
Device Problems
Deflation Problem (1149); 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 02/26/2019 |
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.
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Event Description
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It was reported that the foley catheter fell out of the patient with a deflated balloon.
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Event Description
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It was reported that the foley catheter fell out of the patient with a deflated balloon.
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Manufacturer Narrative
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The reported event was unconfirmed.The evaluation found no leakage observed even when pressure was applied on the sac.The sample underwent a 7 day leak test and no leakage was observed.There was no leakage from the valve.The catheter was dissected and no conditions 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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.-use luer tip syringe to inflate with stated ml of sterile water or -for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.".
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Search Alerts/Recalls
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