Catalog Number 0165L16 |
Device Problems
Burst Container or Vessel (1074); Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
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.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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Event Description
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It was reported that when attempting to inflate the balloon, the foley catheter cap off the balloon popped off and saline leaked from it.It was stated that the catheter was removed due to being defective and a new catheter was placed.
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Manufacturer Narrative
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Upon further review of investigation, bd has determined that this mdr is not reportable.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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Event Description
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It was reported that when attempting to inflate the balloon, the foley catheter cap off the balloon popped off and saline leaked from it.It was stated that the catheter was removed due to being defective and a new catheter was placed.Per customer on 23jan2023, it was reported that no pieces of the foley balloon were found inside of the patient.The foley was removed and replaced with another one.The patient was unharmed.
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Search Alerts/Recalls
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