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

Catalog Number 5C4466P

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the pouches of an unspecified quantity of minicaps had ¿poor sealing¿.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

Devices were received and are currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: fifteen (15) samples were received for evaluation; two (2) open, empty pouches and thirteen (13) unopened pouches.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional under water pressure test was performed on all thirteen unopened samples and zero (0) failures occurred.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.

• 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 - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16526147
• MDR Text Key: 311164293
• Report Number: 1416980-2023-00995
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007694
• UDI-Public: (01)00085412007694
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152129
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4466P
• Device Lot Number: GD912372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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