Model Number 806316 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Tract Infection (2120)
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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 device was not returned.
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Event Description
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It was reported that the patient said she got a uti, but she was not sure what caused it.She also said she was no longer using catheters.It was unknown if treatment was provided.
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Event Description
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It was reported that the patient said she got a uti, but she was not sure what caused it.She also said she was no longer using catheters.It was unknown if treatment was provided.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential failure mode could be ¿materials of construction are not biocompatible¿.A potential root cause for this failure could be "materials of construction are not biocompatible".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿ h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
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Search Alerts/Recalls
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