Model Number 175806N |
Device Problem
Calcified (1077)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that urine was noted to be draining from the balloon port of the foley catheter.The user attempted to aspirate from balloon port for small amount of urine.The balloon was noted to be ruptured and had sediments on the tip when the foley catheter was removed.A new foley catheter was placed with no complications and it was unable to determine if parts of the balloon was remaining in the patient.It was stated that the balloon material appeared to be intact.
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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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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 duplicate 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.H3 other text : the device was not returned.
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Event Description
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It was reported that urine was noted to be draining from the balloon port of the foley catheter.The user attempted to aspirate from balloon port for small amount of urine.The balloon was noted to be ruptured and had sediments on the tip when the foley catheter was removed.A new foley catheter was placed with no complications and it was unable to determine if parts of the balloon was remaining in the patient.It was stated that the balloon material appeared to be intact.
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Search Alerts/Recalls
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