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

Catalog Number T5C4325K

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the twist clamp of a titanium transfer set "could not stop" and keep rotating.This occurred during use of peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: d10, h3, h6.Additional information/correction to d4 lot #, expiration date, and udi #: the lot was mistakenly reported.The lot is unknown for this event (update to asku, ni, ni).H10: the device was received for evaluation.A visual inspection with the naked eye noted a broken occluder feet.The reported condition was verified.The cause of the broken occluder feet could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TITANIUM TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10937422
• MDR Text Key: 219359655
• Report Number: 1416980-2020-07504
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412150703
• UDI-Public: (01)00085412150703
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 12/23/2020

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 Expiration Date: 08/21/2023
• Device Catalogue Number: T5C4325K
• Device Lot Number: H18H21074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1