C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
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Catalog Number 786626 |
Device Problem
Inadequate Instructions for Healthcare Professional (1319)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
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 a urethral stent was required when performing ureteroscopic lithotripsy under general anesthesia at the hospital on (b)(6) 2023.When preparing the items, the nurse found that the model of the bard inlay optima ureteral stent was labeled as 786626.But after unpacking, the diameter of the content stent was shown as 4.7 f, inconsistent with that on the outer package, stent was used.The agent inspected the goods in this lot number and found nine stents having the problem.
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Manufacturer Narrative
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The reported event was confirmed as packaging related.A potential root cause for this failure mode could be ¿incorrect component".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required as a review of the label could not have prevented the reported event.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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that a urethral stent was required when performing ureteroscopic lithotripsy under general anesthesia at the hospital on (b)(6) 2023.When preparing the items, the nurse found that the model of the bard inlay optima ureteral stent was labeled as 786626.But after unpacking, the diameter of the content stent was shown as 4.7 f, inconsistent with that on the outer package, stent was used.The agent inspected the goods in this lot number and found nine stents having the problem.
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