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

Catalog Number T5C4326K

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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 two (2) titanium spike transfer sets were "idled" and would not connect to the titanium adapter.This occurred during preparation at the hospital.The titanium adapter remained in used.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: two (2) actual samples were received for evaluation.A visual inspection with the naked eye was performed with no issues noted.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted.An integrity test was performed with an in house titanium adaptor and there were no leaks or issues noted.The reported condition was not verified.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: 10268106
• MDR Text Key: 198689403
• Report Number: 1416980-2020-03961
• 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: 08/10/2020

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: H19H22097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TITANIUM ADAPTER