BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the twist clamp of two (2) peritoneal dialysis (pd) transfer sets were unable to close completely.This was observed during use of the devices for pd therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the actual devices were not available; however two (2) photographs of the samples were provided for evaluation.The photographs were visually inspected and the white twist clamp not in the lock position was observed.However, without the actual samples, there is not enough information to duplicate the event or determine if the product failed or met specification.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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