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Catalog Number 6393190 |
Device Problems
Collapse (1099); Degraded (1153); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2023).H11: section a through f: the information provide by bd represents all 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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Event Description
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It was reported that sometime post a dialysis catheter placement , weakening and flattening was allegedly found in the plastic around the clamp.It was further reported that the catheter flattened was noted when the catheter was accessed.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm glidepath d/l catheter was returned for evaluation.Two electronic photos were provided for review.Functional, gross visual, tactile and microscopic visual evaluations were performed.Tactile evaluation on the catheter shows no evidence indicating loose fitting near the tissue cuff.Both clamps were noted to be normally expanded while disengaged.Both lumens were patent to infusion and aspiration with no issue.No leaks were noted throughout both tests.Therefore, the investigation is inconclusive for the reported collapse and the degraded issue as the exact circumstances at the time of the reported event was unknown and cannot be verified from the provided photos.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.The information provided by bd represents all 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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Event Description
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It was reported that sometime post a dialysis catheter placement, weakening and flattening was allegedly found in the plastic around the clamp.It was further reported that the catheter flattened was noted when the catheter was accessed.There was no reported patient injury.
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Search Alerts/Recalls
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