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

Catalog Number T5C4326K

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the catheter adapter of a titanium transfer set was damaged, and could not connect to the titanium adapter.This was observed during preparation of the device for peritoneal dialysis therapy.The transfer set was replaced, however, the titanium adapter remained in use.There was no report of patient injury, or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: one actual sample was received for evaluation.A visual inspection with the naked eye noted the catheter adapter malformed and flash was on the inside of the catheter adapter.The reported condition was verified.The cause of the condition was determined to be manufacturing related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 10568265
• MDR Text Key: 207975515
• Report Number: 1416980-2020-05901
• 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: 10/27/2020

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: Health Professional
• Device Catalogue Number: T5C4326K
• Device Lot Number: H19I12070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TITANIUM ADAPTER; TITANIUM ADAPTER