Catalog Number 129414 |
Device Problems
Inaccurate Flow Rate (1249); No Flow (2991)
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Patient Problems
Urinary Retention (2119); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2018 |
Event Type
Injury
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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 after placing the catheter, approximately 4 ml of urine flowed on the day of placement.A bladder scan was completed and confirmed urine in the bladder.The catheter was replaced and 400 ml of urine drained out.
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Event Description
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It was reported that after placing the catheter, approximately 4 ml of urine flowed on the day of placement.A bladder scan was completed and confirmed urine in the bladder.The catheter was replaced and 400 ml of urine drained out.
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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 blockage in the drainage lumen.Water was introduced through the drainage eye and came out of the drainage funnel without difficulty.The sample was sent for a flow rate test and passed.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: "[(6)since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.(7)when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.(8)avoid force on the connecting parts as they may be accidentally disconnected due to the weight of the drainage bag etc.And may cause urine spill.".
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Search Alerts/Recalls
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