MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

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.

• Brand Name: MINICAP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CUERNAVACA; ave. de los 50 metros no. 2; cuernavaca 62578 ; MX 62578
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16787177
• MDR Text Key: 313862048
• Report Number: 1416980-2023-01910
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412353036
• UDI-Public: (01)00085412353036
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ABC4466BA
• Device Lot Number: M23A14B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.