Device Problems
Break (1069); Hole In Material (1293)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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 a pin sized hole was observed in the catheter upon removal by the nurse.
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Event Description
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It was reported that a pin sized hole was observed in the catheter upon removal by the nurse.
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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 product catalog number for this silicone catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product catalog number is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.
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Search Alerts/Recalls
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