Catalog Number 365714 |
Device Problems
Device Operates Differently Than Expected (2913); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/15/2016 |
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 foley catheter was inserted into the patient; urine was able to drain via the catheter; however, it then stopped draining.The catheter was allegedly coming out of the patient.There was an attempt to remove fluid from the balloon, but no fluid returned.The foley came out with the balloon not inflated.Upon inspection, there was a small tear allegedly noted to the balloon that was not noted prior to insertion.No pieces were reported missing.
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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 device was not returned.
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Event Description
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It was reported that the foley catheter was inserted into the patient; urine was able to drain via the catheter; however, it abruptly stopped draining.The catheter was allegedly coming out of the patient.There was an attempt to remove fluid from the balloon, but no fluid returned.The foley came out with the balloon un-inflated.Upon inspection, there was allegedly a small tear noted on the balloon that was not noted prior to insertion.No pieces were reported missing.
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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 state the following: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to 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.The device was not returned.
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Event Description
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It was reported that the foley catheter was inserted into the patient; urine was able to drain via the catheter; however, it abruptly stopped draining.The catheter was allegedly coming out of the patient.There was an attempt to remove fluid from the balloon, but no fluid returned.The foley came out with the balloon un-inflated.Upon inspection, there was allegedly a small tear noted on the balloon that was not noted prior to insertion.No pieces were reported missing.
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Search Alerts/Recalls
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