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Catalog Number 6393190 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that three months post dialysis catheter placement, the extension part of the device was allegedly broken.It was further reported that the extension part of the catheter allegedly leaked.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2024) h11: section a through f ¿ 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.H3 other text : device not returned.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were provided for review.The photo shows the glidepath catheter and a crack was noted on the extension led of the red luer proximal to the clamp.Therefore, the investigation is confirmed for the reported fracture issue.However, the investigation is inconclusive for the reported fluid leak as no objective evidence was provided for review.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.H10: d4 (expiration date: 12/2024), g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f ¿ 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 three months post a dialysis catheter placement, the extension part of the device was allegedly broken.It was further reported that the extension part of the catheter allegedly leaked.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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Search Alerts/Recalls
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