Catalog Number UNKNOWN |
Device Problems
Loss of or Failure to Bond (1068); Material Separation (1562)
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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.
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Event Description
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It was reported that the fitting between the bard catheter and the bag kept coming apart and was not secured back together.The holders that stuck to the skin only lasted for a short time.As a result, the patient needed help to put a new bag on and to make the bag secured on the leg.The customer was currently using 18fr catheter and enquired about a longer catheter or other method to secure the bag.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to ¿pad material incompatible with adhesive (poor surface treatment)".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the statlock foley product ifus were found to be adequate based on past reviews.
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Event Description
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It was reported that the fitting between the bard catheter and the bag kept coming apart and was not secured back together.The holders that stuck to the skin only lasted for a short time.As a result, the patient needed help to put a new bag on and to make the bag secured on the leg.The customer was currently using 18fr catheter and enquired about a longer catheter or other method to secure the bag.
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Search Alerts/Recalls
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