Catalog Number 165812 |
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.
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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 (b)(6) 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.No root cause could be found because the reported event was unconfirmed.It was received one 2 way all silicone foley catheter and water syringe in its unopened original package.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and concentricity was found within specification.Catheter rested with no leaks.The inhouse syringe was connected and it was able to passively return the 10 ml with no issues or cuffing.The same test was performed with the returned syringe and no defects were evidenced.A dhr is not required since the reported failure was unconfirmed.The reported event is unconfirmed a labeling review is not required.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 the diffusion from silicone foley catheter balloon.The customer have on all three sizes 12 (lot# mygy2871/ 14 (lot# mygy0098)/16 (lot# mygv0659)) 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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Search Alerts/Recalls
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