Catalog Number FOL0101 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/17/2024 |
Event Type
Injury
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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.H3 other text : device was not returned.
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Event Description
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Critical care nurses reported that urinary meatus injury was a device use related complication that resulted in patient injury requiring medical or surgical intervention - intervention not specified.It was unknown what medical intervention was provided for urinary meatus injury.
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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.H3 other text : the device was not returned.
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Event Description
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Critical care nurses reported that urinary meatus injury was a device use related complication that resulted in patient injury requiring medical or surgical intervention - intervention not specified in relation to product fol0100- sl foley swivel silicone folyadltw/pershforltxcathsl foley swivel siliconestatlock.Per additional information from ucc received on 07feb2024, upon receipt of the final dataset for the statlock foley stabilization device.Previously had fol0100 as the product code.This should have been fol0101 and has been updated in the forms attached.
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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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Critical care nurses reported that urinary meatus injury was a device use related complication that resulted in patient injury requiring medical or surgical intervention - intervention not specified in relation to product fol0100- sl foley swivel silicone folyadltw/pershforltxcathsl foley swivel siliconestatlock.Per additional information from ucc received on 07feb2024, upon receipt of the final dataset for the statlock foley stabilization device.Previously had fol0100 as the product code.This should have been fol0101 and has been updated in the forms attached.
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Search Alerts/Recalls
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