Model Number 73018L |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.
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Event Description
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It was reported that there was a hole in the tubing of the catheter which caused urine to leak.The complainant reportedly replaced the catheter.
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Manufacturer Narrative
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The reported issue (it was reported that there was a hole in the tubing of the catheter which caused urine to leak.Complainant reportedly replaced the catheter) was confirmed.Per visual inspection no defects were found.Per functional evaluation the sample was inflated with 30cc with a mix of blue methylene and tap water and no leakage was observed by inflation lumen.Then, the drainage and irrigation lumens were tested and a leakage was observed by the irrigation lumen below the trifurcation area due to a cut on the shaft.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
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Event Description
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It was reported that there was a hole in the tubing of the catheter, which caused urine to leak.The complainant reportedly replaced the catheter.
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Search Alerts/Recalls
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