Model Number 0168L16 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2022 |
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 survey respondent stated no, the urinary drainage was not achieved from use of this product because the patient wanted it removed in relation to biocath foley catheter pre-connected to 2l bardia bed bag, standard length, french size 16.
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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 the survey respondent stated no, the urinary drainage was not achieved from use of this product because patient wanted it removed in relation to biocath foley catheter pre-connected to 2l bardia bed bag, standard length, french size 16.
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Search Alerts/Recalls
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