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

Catalog Number 5C4466P

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem Peritonitis (2252)

Event Date 03/18/2023

Event Type  Injury  

Event Description

It was reported that the sterile packaging of an unspecified quantity of minicaps were not sealed properly.The unspecified quantity of minicaps were used during peritoneal dialysis (pd) therapy which resulted in peritonitis.The patient was not hospitalized for peritonitis.On an unspecified date, the patient was placed on a fourteen-day regimen of unspecified peritoneal antibiotics for peritonitis.At the time of this report, the patient was recovering from peritonitis.The action taken with pd therapy was not reported.No additional information is available.

Manufacturer Narrative

F2: uf / importer report number - mw5122874.H9: correction/removal report number - 1019003-02/01/2023-001-r.The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: device manufacture date for lot # gd912051: 09/30/22 to 10/07/22.Sample analysis was performed through visual inspection of the twenty-two (22) actual complaint samples.Upon visual inspection, cavity 7 revealed minimal creasing along the edges of the pouch.A functional test was performed on all provided samples and no failures occurred for underwater pressure testing.There is a recall potentially associated with this issue: 1019003-02/01/2023-001-r.The reported lot was recalled.These devices are packaged in foil pouches, which may have been incorrectly sealed, i.E., the pouches may have open or weak seals.This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the minicap, which could lead to the potential for inadequate disinfectant.A review of the manufacturing record was performed for this lot number.During review, two nonconformances related to open/weak seals were identified.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: 17864722
• MDR Text Key: 324847572
• Report Number: 1416980-2023-04998
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• 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: GD912051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention