C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
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Catalog Number 787626 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
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 there was no fracture of the ureteral stent observed from the outer packaging, and when the stent was connected, it was found that there was a crack after opening the inner package, and it was broken when touched, and the stent was not used and did not enter the human body.
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Search Alerts/Recalls
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