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 Patient Involvement (2645)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a minicap transfer set had a connection issue; further described as ¿transfer set connector was spined with no traction¿ and ¿was hard to connect¿.This was observed prior to use of the device for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information in d4: lot# and h6.D4: lot#: the reported, lot 20e3106 is not recognized as a valid lot.H10: the device was not returned.And the valid lot number is unknown.Therefore, a device analysis could not be completed.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: 11083680
• MDR Text Key: 224755025
• Report Number: 1416980-2020-08092
• 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: 01/25/2021

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: 20E3106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1