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Catalog Number 0165L16 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that there was poor urinary flow due to blockage in the foley catheter lumen.It was clogged within one week of indwelling (serial # (b)(6).As per information mentioned in the internal bd comments on (b)(6) 2023, stated that they confirmed that there was a leak from the drainage eye (serial # (b)(6).No abnormalities were found in other areas.No abnormalities were detected throughout the bag.As per follow up information received on (b)(6) 2023, stated that the catheters had 2 different serial# (serial # (b)(6) and serial # (b)(6).
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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 there was poor urinary flow due to blockage in the foley catheter lumen.It was clogged within one week of indwelling (serial # (b)(6)).As per information mentioned in the internal bd comments on 28nov2023, stated that they confirmed that there was a leak from the drainage eye (serial # (b)(6)).No abnormalities were found in other areas.No abnormalities were detected throughout the bag.As per follow up information received on 30nov2023, stated that the catheters had 2 different serial# (serial # (b)(6), serial # (b)(6), serial # (b)(6) and serial # (b)(6)).
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as this event 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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Search Alerts/Recalls
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