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Model Number 5833350 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
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, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2023) 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 : device not returned.
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Event Description
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It was reported that during a dialysis catheter placement procedure, the introducer needle was allegedly ruptured.It was further reported that the introducer needle allegedly leaked air.Furthermore, saline allegedly leaked in the pink joint of the introducer needle when injected.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a dialysis catheter placement procedure, the introducer needle was allegedly ruptured.It was further reported that the introducer needle allegedly leaked air.Furthermore, saline allegedly leaked in the pink joint of the introducer needle when injected.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: 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: the physical device was not returned for evaluation.However, one photo was provided for review.The photo shows the introducer needle with a protective cover over it.Therefore, the investigation is inconclusive for the reported fracture, air/gas in device and leak issues as no clear evidence of the reported event was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2023).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 : device not returned.
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Search Alerts/Recalls
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