Catalog Number 786426 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
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 bard represents all of 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 bard.
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Event Description
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It was reported that when in use during operation, the stent was found occluded so that the urine could not be drained.As per the follow up information received via ibc on 20sep2023, the ureteral stent was used for laparoscopic right ureteral bladder replantation and was replaced with a new stent when the stent was found to be blocked during intraoperative use and urine could not be drained.
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Manufacturer Narrative
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The reported event is unconfirmed as the product meets specifications.Visual evaluation noted visual requirements state to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.No defects were evaluated while performing the visual inspection.The suture and pigtail straightener were not provided for evaluation.Dimensional evaluation noted dimensional requirements state the od is to be 0.061" ± 0.002" and the guidewire to be 0.035" ± 0.001".The sample passed od measuring at 0.0627" using a laser micrometer.When inserting the guidewire there was no hesitation.No root cause could be found because the reported event was unconfirmed.A dhr reviews are not required for this complaint.The labelling review is not required as the reported event is unconfirmed.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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that when in use during operation, the stent was found occluded so that the urine could not be drained.As per the follow up information received via ibc on 20sep2023, the ureteral stent was used for laparoscopic right ureteral bladder replantation and was replaced with a new stent when the stent was found to be blocked during intraoperative use and urine could not be drained.
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Search Alerts/Recalls
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