Catalog Number 119314 |
Device Problems
Dent in Material (2526); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
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 after being inserted into the patient, the foley catheter was removed while the balloon was still filled with sterile water.
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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 after being inserted into the patient, the foley catheter was removed while the balloon was still filled with sterile water.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.The information provided by bd represents all of 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 after being inserted into the patient, the foley catheter was removed while the balloon was still filled with sterile water.Per follow up received on (b)(6) 2024, the exact issue faced by the customer was natural removal of the follow catheter.
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Search Alerts/Recalls
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