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 stated that the ureteral stent package 777426 opened, the stent modulator was removed outside the patient's body, and when the stent tube was installed and threaded into the guidewire, the stent tube broke and did not affect the patient.It was noted that the issue was discovered before usage on the patient.
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