BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number 5C4482 |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the sterile packaging of two (2) peritoneal dialysis (pd) transfer sets were damaged (opened).This was found prior to use of the device for pd therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
E1: initial reporter facility name: ¿¿¿¿¿¿¿.E1: initial reporter city: ¿¿, ¿¿.A device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
Additional information h3, h6 and h10.H10: two actual samples were received for evaluation in open pouches.A visual inspection was performed which identified a material transfer in the seal locations of both pouches which indicated both pouches were previously sealed.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|