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Catalog Number 0165L14 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
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.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that several hours after placement, no urine flowed out.An attempt was made to remove the fluid.However, it was difficult to remove the fluid, so they consulted a urologist, who informed that they had to cut the inflation lumen and drain the fluid.As per information mentioned in the internal bd comments on 14nov2023, stated that they confirmed that the valve part was disconnected.No abnormalities can be confirmed in other areas.They cut the inlet tube and discarded the bag.
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Event Description
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It was reported that several hours after placement, no urine flowed out.An attempt was made to remove the fluid.However, it was difficult to remove the fluid, so they consulted a urologist, who informed that they had to cut the inflation lumen and drain the fluid.As per information mentioned in the internal bd comments on 14nov2023, stated that they confirmed that the valve part was disconnected.No abnormalities can be confirmed in other areas.They cut the inlet tube and discarded the bag.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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