Catalog Number 119314 |
Device Problems
Difficult to Remove (1528); Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
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 there was difficulty in draining sterile water from the foley catheter during the pretest.When the user tried to drain the fixed water using a syringe from the tray, they were able to drain only 7ml of fixed water in about 1 minute.
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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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Event Description
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It was reported that there was difficulty in draining sterile water from the foley catheter during the pretest.When the user tried to drain the fixed water using a syringe from the tray, they were able to drain only 7ml of fixed water in about 1 minute.
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Search Alerts/Recalls
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