Catalog Number 165816 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Discomfort (2330)
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Event Date 01/18/2024 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that the diffusion from silicone foley catheter balloon.The customer have on all three sizes of 12/14 /16 experienced that the catheter balloon which was filled with the provided syringe.That after 3 weeks the customer had a volume of 4 ml each in the balloon, this creates discomfort for the user.No medical intervention was reported.
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Event Description
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It was reported that the diffusion from silicone foley catheter balloon.The customer have on all three sizes of 12/14 /16 experienced that the catheter balloon which was filled with the provided syringe.That after 3 weeks the customer had a volume of 4 ml each in the balloon, this creates discomfort for the user.No medical intervention was reported.
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Manufacturer Narrative
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The reported event was unconfirmed.The device is considered within specification, and the reported event is considered unconfirmed.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.The reported event is unconfirmed a labeling review is not required.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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