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

Catalog Number 5C4483

Device Problem Fitting Problem (2183)

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

Event Date 06/29/2021

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 connection issue between a minicap extended life pd transfer set and thetitanium adapter; further described as ¿catheter connector and catheter adapter did not match well¿.This was observed during set up of the device for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: d9, h3, h6, h10.H10: the sample was received for evaluation with the original cap attached to the female connector.A visual inspection was performed with naked eye with no issues noted.Functional testing including leak, clear passage, clamp function and integrity (seal surface) testing were performed with no issues noted.The reported condition was not verified.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
• MDR Report Key: 12222072
• MDR Text Key: 263366187
• Report Number: 1416980-2021-04562
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): Y
• PMA/PMN Number: K192705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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: 5C4483
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1