It was reported that they used lubri-sil bard tray catheter with bard hydrogel coating/standard length size 14ch for catheterization unfortunately patient returned back to hospital two times in 2 weeks as the balloon burst, and the catheter fell out.Second incident resulted as well with visible blood clots, and it did not look like the catheter was working for this patient at all.They asked to recommend other type of catheters which they can use with statlock stabilization.Patient was 21-year-old on the wheelchair and was fully dependent on their mother.Customer was looking for alternatives as this patient wanted to continue using statlock and had a latex allergy.No medical intervention was reported.
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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.H3 other text : the device was not returned.
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