BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number 5C4482 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1: initial reporter facility name: e1: initial reporter city: the device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the twist clamp of the minicap transfer set was unable to close; further described as ¿the twisted clamps are unable to close tightly, the concave-convex section are unable to attach tightly." this was observed during before use of the device for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information was added to h3, h6 and h10.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was not verified.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.
|
|
Search Alerts/Recalls
|
|
|