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Model Number 5733690 |
Device Problems
Material Discolored (1170); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2023 |
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, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).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.H3 other text : device pending return.
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Event Description
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It was reported that one month and three days post drainage catheter placement, while flushing with saline, swelling was allegedly noted.It was further reported that leakage was allegedly found in the catheter under fluoroscopy.There was no reported patient injury.
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Event Description
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It was reported that one month and three days post drainage catheter placement, while flushing with saline, swelling was allegedly noted.It was further reported that leakage was allegedly found in the catheter under fluoroscopy.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: one 19cm hemosplit d/l catheter was returned for evaluation.Gross visual, tactile and functional testing were performed.In addition to the returned physical sample, one electronic image was provided for review.The investigation is confirmed for the reported fluid leak and identified discoloration issue as there is contrast extravasation in the area of the cuff noted from the provided video loop image and during visual evaluation discoloration was noted to the proximal end of the catheter.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 07/2024).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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Search Alerts/Recalls
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