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

Catalog Number 5C4482

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that the clamp of a minicap transfer set could not be closed and leaked.This occurred during use of the device for peritoneal dialysis (pd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

E1: initial reporter facility name: the device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed and broken occluder legs beneath the twist clamp were observed.Clear passage testing was performed and no issues were observed.Leak testing was performed and an internal leak through the closed twist clamp was observed.No external leaks were observed.The fluid through the closed twist clamp was due to broken occluder legs.The cause of the broken occlude legs could not be determined, however transfer sets exposed to chemical agents such as foreign solvents, dyes, or cleaning agents may cause damage to the transfer set materials.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: 19143492
• MDR Text Key: 340939244
• Report Number: 1416980-2024-01802
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007731
• UDI-Public: (01)00085412007731
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152675
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4482
• Device Lot Number: H23C23058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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