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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It was reported that when the ureteral stent was inserted with a boko zebra m0066701121 guidewire, the insertion was not smooth, and there was unknown resistance, so the tube was broken, and the stent was removed and found to be deformed, and the stent was reopened to complete the catheterization.Per additional information via email from ibc on 08apr2024, this device was not used on the patient.After discovering the problem, a new packaging was opened and used on the patient.
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