Catalog Number 900016A |
Device Problems
Restricted Flow rate (1248); No Flow (2991)
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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 10/10/2018 |
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 there was no urine flow into the bag after placement.
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Manufacturer Narrative
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The reported event was unconfirmed.The evaluation found no abnormalities on the returned sample.Water was introduced through the inlet tube and came out from the urine meter to the drainage bag without difficulty.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.Precautions for use (7) pull the catheter to seat the balloon at the level of the bladder neck and secure placement.(8) keep the drainage bag below the bladder level without touching the floor.(9) connect the lead wire of catheter to temperature monitor with extension cable.(10) secure drainage bag to bed sheet with clip to ensure that there is neither twist nor kink in the cube.".
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Event Description
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It was reported that there was no urine flow into the bag after placement.
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Search Alerts/Recalls
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