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

Catalog Number T5C4326K

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone no:.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the titanium spike of a transfer set assembly (short) was loose and ¿the spike was not fixed to flow control barrel completely before use¿.This issue was identified at the hospital before use for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation.A visual inspection with the naked eye and magnification noted the spike separated from the main body; the insert chip was present.There was no evidence of solvent inside the main body.Functional testing including leak, clear passage and clamp function testing were performed with no issues noted.The reported condition was verified.The cause of the condition is related to inadequate solvent application during manufacturing.A nonconformance has been opened to address this issue.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: 11581616
• MDR Text Key: 245094203
• Report Number: 1416980-2021-01661
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1