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

Catalog Number 5C4466P

Device Problems Contamination (1120); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

It was reported that the inside of three (3) minicaps pouches appeared ¿wet¿.This was observed during set up of the devices for peritoneal dialysis therapy.The shipping carton appeared to be wet.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The event occurred on an unspecified date of (b)(6) 2023.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured september 9, 2022 to september 16, 2022.H10: the actual devices were not available; however, three (3) companion samples were received for evaluation.A visual inspection of the samples was performed which revealed there was moisture present inside the pouches of the minicaps.Further evaluation concluded that the moisture was due to the high water content of the povidone iodine solution and the moisture inside the pouch was water condensation.This condensation is inherent to the povidone iodine solution and does not impact the function of the minicap device.Therefore, the reported condition was not verified as a product defect.The sample analysis determined that the samples met all specifications and the products were found to be conforming.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 - 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: 16702612
• MDR Text Key: 312899081
• Report Number: 1416980-2023-01633
• 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
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 5C4466P
• Device Lot Number: GD911955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2022
• 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: Female