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

Catalog Number 5C4483

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a separation between the female connector (dark blue) and the main body (light blue) of the twist clamp on a minicap transfer set.The event was further described as ¿ the dark blue part it just keeps on rolling and unable to unhook.The dark blue portion where it meets the light blue portion of the transfer set malfunctioned/did not stay secure together¿.This occurred after treatment of peritoneal dialysis therapy peritoneal dialysis therapy.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to d9, h3, h6, and h10: h10: the device was received for evaluation.Visual inspection was performed and a separation was observed between the female connector and main body.Leak, clear passage, and clamp function testing were performed and no issues were observed.The reported condition was verified.The cause of the condition was determined to be manufacturing related due to an inadequate solvent bond between the female connector, insert chip, and main body.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 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: 18979636
• MDR Text Key: 338697576
• Report Number: 1416980-2024-01343
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007748
• UDI-Public: (01)00085412007748
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192705
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4483
• Device Lot Number: H23J10051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Date Device Manufactured: 10/10/2023
• 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