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Catalog Number 6393190 |
Device Problems
Material Discolored (1170); Stretched (1601); Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2024 |
Event Type
malfunction
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Event Description
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It was reported that one month and twenty-one days post a dialysis catheter placement, the catheter hubs were allegedly getting weaker, causing ballooning while flushing and also catheter hub color was allegedly changed to pale yellow.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 will be 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: 05/2025).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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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.However, three electronic photos were provided for review.The first and second photo shows the catheter discoloration.Material stretch and protrusion was noted to the blue luer near the bifurcation area.Therefore, the investigation is confirmed for the reported material discoloration, material stretch and protrusion.A definitive root cause could not be determined based upon the provided 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: 05/2025), 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 one month and twenty-one days post a dialysis catheter placement, the catheter hubs were allegedly getting weaker, causing ballooning while flushing and also catheter hub color was allegedly changed to pale yellow.There was no reported patient injury.
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Search Alerts/Recalls
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