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

Catalog Number 5C4466P

Device Problem Product Quality Problem (1506)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient experienced peritonitis.The cause of the peritonitis was unknown.The caregiver reported the ¿minicaps did not seem to have as much iodine as other lot numbers", further specified as "had some iodine, just not as much as usual".It was not reported if the patient was hospitalized for the event.Treatment, patient outcome and action with pd therapy was not reported.No additional information is available.

Manufacturer Narrative

The peritonitis occurred on an unspecified date in (b)(6) 2023.Correction/removal report number:1019003-02/01/2023-001-r.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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.As a sample was not returned for analysis, further investigation into the cause could not be performed, and the cause of the peritonitis event could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: device manufacture date: 10/21/22 to 10/28/22.The actual device was not available; however, a companion sample was received for evaluation.Visual inspection of the companion sample did not identify any abnormalities that could have contributed to the reported condition.A visual inspection of the sponge revealed the presence of iodine.The returned sample met specification.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: 16592128
• MDR Text Key: 311775336
• Report Number: 1416980-2023-01269
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 5C4466P
• Device Lot Number: GD912112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Other