Device Problems
Difficult to Remove (1528); Folded (2630); Mushroomed (2987)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/06/2018 |
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.The information provided by bard 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 bard.The device was not returned.
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Event Description
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It was reported that the balloon of the latex-free foley catheter "appears to be partial folded over the tip" and got stuck in the urethra of a patient.It was reported that "urology was called and they were able to remove without trauma.".
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this silicone catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.
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Event Description
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It was reported that the balloon of the latex-free foley catheter "appears to be partial folded over the tip" and got stuck in the urethra of a patient.It was reported that "urology was called and they were able to remove without trauma.".
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Search Alerts/Recalls
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