Catalog Number UNKNOWN |
Device Problems
Inflation Problem (1310); No Flow (2991)
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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 balloon was difficult to inflate.The complainant alleged that water would not go inside the catheter.No patient injury was reported.
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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.Although the product family is unknown, the product ifus are found to be adequate based on past reviews.(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 catheter balloon was difficult to inflate.The complainant stated that water would not go inside of the catheter.No patient injury was reported.
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Search Alerts/Recalls
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