Device Problems
Bent (1059); Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 catheters were bent.Complainant alleged that the catheters were over stuffed in the shipping box causing them to be bent.Complainant alleged that he was still able to use catheters to void.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, a device history record could not be reviewed.Although the product family is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.(b)(4).
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Event Description
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It was reported that the catheters were bent.Complainant alleged that the catheters were over stuffed in the shipping box causing them to be bent.Complainant alleged that he was still able to use catheters to void.No patient injury was reported.
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Search Alerts/Recalls
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