Catalog Number FOL0102 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
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 patient was using statlock with foley catheter as a suprapubic catheter.Patient¿s catheter fell out; the hospital replaced the catheter and informed that the balloon deflated due to a hole caused by the statlock.Patient states catheter pinch-hole occurred at the bifurcation point on the swivel.
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Event Description
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It was reported that patient was using statlock with foley catheter as a suprapubic catheter.Patient¿s catheter fell out; the hospital replaced the catheter and informed that the balloon deflated due to a hole caused by the statlock.Patient states catheter pinch-hole occurred at the bifurcation point on the swivel.
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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 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.H3 other text : the device was not returned.
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Search Alerts/Recalls
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