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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the catheter adapter of a uv-flash solution transfer set was ¿idled¿ and could not connect to the patient¿s titanium adapter.This occurred during use for peritoneal dialysis therapy.There was no allegation against the titanium adaptor and it was still in use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information in b5, d1, d4, h3, h6.B5: upon clarification from the customer, the device was a titanium transfer set.Update "uv-flash solution transfer set" to "titanium transfer set".H10: the actual device was received for evaluation.A visual inspection was performed with no issues noted.Functional testing including leak, clear passage, and clamp function testing was performed with no issues noted.Integrity testing was performed between the patient connector and in-lab titanium adapter; no issues or leaks were observed.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: 11388398
• MDR Text Key: 233972843
• Report Number: 1416980-2021-00930
• 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: 03/30/2021

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: H20E06119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TITANIUM ADAPTOR