Model Number 129416M |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
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.The device was not returned.
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Event Description
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It was reported that the foley catheter was aseptically inserted into a patient and balloon was inflated prior to surgical procedure in operating room.Stated that after 1 hour it was noted that the urine was not draining and attempted to irrigate without success.Customer stated that the foley was aseptically removed and a new foley with different lot number inserted without incident.Also stated that the urine was noted to be draining and surgery was not interrupted.Per additional information received via email on 02feb2022, customer stated that the foley catheter was aseptically inserted into a patient and balloon was inflated in operating room prior to surgical procedure.Certified registered nurse anesthetists gave fluid bolus and diuretic.Stated that urine was not draining.Registered nurse attempted to flush the catheter and met with resistance and felt hardness at the flush/balloon inflation junction (blockage).Stated foley was removed and new foley with different lot inserted without resistance and immediate urine return.Surgery was not delayed, and patient had no injuries.
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Event Description
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It was reported that the foley catheter was aseptically inserted into a patient and balloon was inflated prior to surgical procedure in operating room.Stated that after 1 hour it was noted that the urine was not draining and attempted to irrigate without success.Customer stated that the foley was aseptically removed and a new foley with different lot number inserted without incident.Also stated that the urine was noted to be draining and surgery was not interrupted.Per additional information received via email on (b)(6) 2022, customer stated that the foley catheter was aseptically inserted into a patient and balloon was inflated in operating room prior to surgical procedure.Certified registered nurse anesthetists gave fluid bolus and diuretic.Stated that urine was not draining.Registered nurse attempted to flush the catheter and met with resistance and felt hardness at the flush/balloon inflation junction (blockage).Stated foley was removed and new foley with different lot inserted without resistance and immediate urine return.Surgery was not delayed, and patient had no injuries.Per additional information via form with sample returned on (b)(6) 2022, it was reported that the foley catheter inserted, there was no urine return so they gave fluid bolus but no urine return.Representative attempted to irrigate the foley catheter but unable to perform the function and replaced the catheter.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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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Search Alerts/Recalls
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