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

Catalog Number T5C4325K

Device Problem Misconnection (1399)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use of a tsunagu device, the spike of a titanium transfer set connected to the green pull ring cap of a reguneal manual bag.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the sample was received for evaluation with a cap on the spike.A visual inspection was performed with the naked eye with no issues noted.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Using the uv flash machine, the transfer set was connected and disconnected to an in lab disconnect cap and molded port with no issues.The returned sample met specification.The reported condition was not verified.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: 12436430
• MDR Text Key: 270303060
• Report Number: 1416980-2021-05494
• Device Sequence Number: 1
• Product Code: KDJ
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: T5C4325K
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REGUNEAL 1.5 UV TWIN BAG