BAXTER HEALTHCARE CORPORATION MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number ABC4466BA |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the individual packaging (overpouch) of an unspecified quantity of minicaps were damaged.It was further described as the caps "do not have the bubble in the packaging, the packaging was crushed and it comes off easily, the caps are opened packaging".This was observed before use of the devices for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
H10: twenty-six (26) actual samples were received for evaluation.A visual inspection with the naked eye identified roughness and in some cases flattened aluminum foil.Nineteen (19) samples were found opened on the sides of the aluminum foil and seven (7) samples were found closed.The samples have aluminum roughness, which indicates a manipulation of the samples potentially during preparation of the therapy.The reported condition was verified.The cause of the condition could not be determined; however, a potential cause is user related.Fourteen (14) retention samples were also evaluated.A visual inspection was performed with no issues noted; the units were without damage, cuts or wrinkles that could affect their operation.In addition, no openings were identified on the sides of the units.The reported condition was not verified on the retention samples.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
|
|
|