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

Catalog Number R5C4482

Device Problems Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It was reported that there was a separation between the female connector and main body of a minicap transfer set.This occurred during a routine transfer set change.A sample bag was attached to the new transfer set to check the tube patency.When the nurse tried to disconnect the sample bag they were was unable to do so.The tube would not come free and was unscrewing from the inside.There were no cuts, hole or leaks to the tube.The transfer set was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.A visual inspection with the naked eye noted a female connector separated from the main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was verified.The cause of the condition was related to inadequate solvent application to the main body during the manufacturing process.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 TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17854237
• MDR Text Key: 324729835
• Report Number: 1416980-2023-04963
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412008776
• UDI-Public: (01)00085412008776
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R5C4482
• Device Lot Number: H23C07051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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: SAMPLE BAG