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

Catalog Number R5C4483

Device Problems Crack (1135); Failure to Disconnect (2541)

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

Event Date 12/23/2022

Event Type  malfunction  

Event Description

It was reported that the minicap transfer set had a connection issue and was observed to be damaged.Additionally, the transfer set would not disconnect from the capd bag.The patient "tried to pull harder to disconnect" the set and the transfer set's main body cracked.The line was changed and the pd fluid was clear.This occurred during an unspecified process step of 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

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

Manufacturer Narrative

H10: the actual device was not available; however a photograph of the sample was provided for evaluation.The photograph was visually inspected and showed damage on the light blue main body.The reported damaged crack/ broken twist clamp was verified.The cause of damaged crack/ broken twist clamp could not be determined; however, exposure to chemical agents such as hydrogen peroxide, alcohol or bleach as listed on product packaging can damage the transfer set materials.The reported connection issue at the female connector could not be confirmed or refuted.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The sample was received for evaluation with a minicap attached to the female connector.A visual inspection with the naked eye noted a cracked main body and broken occluder leg.An unknown substance was observed around the threads and inside the twist clamp.Clear passage testing was performed and no issues were observed.Leak testing and clamp function testing were performed and a leak through the set with the twist clamp in closed position was observed.There was no external leak noted.The mini cap was connected and disconnected by hand with no issues observed, therefore the reported connection issue was not verified.The cause of the leak was due to the broken occluded leg.The cause of the broken occlude leg could not be determined, however this type of damage is consistent with exposure to chemical agents such as foreign solvents, dyes, or cleaning agents.A nonconformance has been opened to address this issue.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: 16199513
• MDR Text Key: 308072398
• Report Number: 1416980-2022-07441
• Device Sequence Number: 1
• Product Code: KDJ
• 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,Followup
• Report Date: 03/21/2023

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: Lay User/Patient
• Device Catalogue Number: R5C4483
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/06/2023; 03/09/2023
• Supplement Dates FDA Received: 02/17/2023; 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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