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 Type  malfunction  

Manufacturer Narrative

Initial reporter phone number (additional): (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the individual packaging of thirty-one (31) minicaps were damaged; further described as ¿minicaps came out soft¿ and ¿they come almost uncovered." this was observed prior to 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

H10: the actual devices were not available; however, fourteen (14) retention samples were evaluated at the plant.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.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: 16521407
• MDR Text Key: 311090361
• Report Number: 1416980-2023-00968
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412353036
• UDI-Public: (01)00085412353036
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: ABC4466BA
• Device Lot Number: M22I28A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2022
• 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
• Patient Sex: Male