Catalog Number A947316 |
Device Problems
Hole In Material (1293); Leak/Splash (1354)
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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.The device was not returned.
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Event Description
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It was reported that the catheter had small poke holes in the back, which resulted in urine leaking on the floor.There were multiple pin prick holes in the back of the bag.The patient had the foley inserted in the operating room and the holes were found 5 hours later.The patient was never out of the bed and the catheter was never moved from the bedside.
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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 instructions for use states the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." (b)(4).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 the catheter had small poke holes in the back, which resulted in urine leaking on the floor.There were multiple pin prick holes in the back of the bag.The patient had the foley inserted in the operating room and the holes were found 5 hours later.The patient was never out of the bed and the catheter was never moved from the bedside.
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Search Alerts/Recalls
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