Catalog Number 175816 |
Device Problem
No Flow (2991)
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Patient Problem
Urinary Retention (2119)
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Event Type
Injury
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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 was not draining.The patient was allegedly given lasix for low urine output; however, the patient did not actually have low out put.It was determined that the low output was allegedly a result of the catheter not draining.
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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: "caution: do not aspirate urine through drainage funnel wall.Visually inspect the product for any imperfections or surface deterioration prior to use.Single patient use only.Do not reuse.Do not resterilize." (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 was not draining.The patient was allegedly given lasix for low urine output; however, the patient did not actually have low out put.It was determined that the low output was allegedly a result of the catheter not draining.
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Search Alerts/Recalls
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