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Catalog Number 6393270 |
Device Problems
Backflow (1064); Reflux within Device (1522); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
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 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 (expiry date: 03/2024).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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Event Description
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It was reported that sometime post a dialysis catheter placement in the right jugular vein, after flushing and locking as per the instruction for use, the blood was allegedly found to be back into the catheter just before the clamp.There was no reported patient injury.
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Event Description
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It was reported that sometime post a dialysis catheter placement in the right jugular vein, after flushing and locking as per the instruction for use, the blood was allegedly found to be back into the catheter just before the clamp.There was no reported patient injury.
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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 sample was not returned for evaluation.Two electronic photos were provided for review.The photos show one glidepath catheter implanted in the patient.Reflux of blood and a air bubble were noted in the blue luer.Therefore, the investigation is confirmed for the reported blood found to be back into the catheter just before the clamp and confirmed for identified air bubble within the device as noted in the photo.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: 03/2024), g3, h6 (method).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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Search Alerts/Recalls
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