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

Catalog Number 5C4366P

Device Problem Fitting Problem (2183)

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

Event Type  malfunction  

Event Description

It was reported that six (6) ultra set disposable disconnect y-sets had a connection issue; further described as ¿does not always tighten to the transfer set." the thread of the y-set is stripped.This occurred during set up 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

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

Manufacturer Narrative

H10: four (4) samples were received for evaluation.A visual inspection was performed with naked eye with no issues noted.Functional testing including clear passage and clamp function testing were performed with no issues noted.Leak testing was performed using an in lab female connector connected to the luer and there were no issues or leaks observed.The reported condition was not verified for the four returned samples.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: CAPD DISCONNECT Y 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: 16787502
• MDR Text Key: 313947129
• Report Number: 1416980-2023-01912
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412030579
• UDI-Public: (01)00085412030579
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K961825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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: Lay User/Patient
• Device Catalogue Number: 5C4366P
• Device Lot Number: H22K09045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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: MINICAP; TRANSFER SET
• Patient Age: 81 YR
• Patient Sex: Female