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 Date 02/15/2023

Event Type  malfunction  

Event Description

It was reported that six (6) minicaps had a weak or incomplete seal that runs to the outer edge of the packaging.This occurred during an unspecified step of peritoneal dialysis (pd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: four (4) samples were received for evaluation; the other two (2) samples were not received and therefore could not be evaluated.A visual inspection with the naked eye noted the pouches presented creases in the seal located at the top and bottom of the pouches.A functional under water pressure test was performed on all four samples and one failure occurred; the other three (3) samples passed the under-water pressure test.The reported condition was verified.The cause of the condition was manufacturing related due to a timing issue/sequencing logic issue during the pouch sealing process with the sealing machine.A nonconformance has been opened to address this issue.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: 16523910
• MDR Text Key: 311162612
• Report Number: 1416980-2023-00984
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007694
• UDI-Public: (01)00085412007694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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: GD912204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1019003-02/01/2023-001-R
• Patient Sequence Number: 1
• Patient Sex: Female