Device Problems
Device Slipped (1584); Device Dislodged or Dislocated (2923)
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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.
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Event Description
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It was reported that the ureteral catheter had expelled with the balloon still inflated.
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Event Description
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It was reported that the urethral catheter had expelled with the balloon still inflated.
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Manufacturer Narrative
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The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿imperfection in the balloon due to process.¿ it was unknown whether the device had met specifications or if there was a relationship between the reported event and the device.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bard was unable to determine the associated labelling to review.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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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the ureteral catheter had expelled with the balloon still inflated.
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Event Description
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It was reported that the ureteral catheter had expelled with the balloon still inflated.
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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.Correction: d1, d2, g5.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.
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Search Alerts/Recalls
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