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

Catalog Number T5C4326K

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

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 connection between the patient adaptor of a titanium transfer set and the titanium adaptor were "loose and could not connect".This was noticed during use of peritoneal dialysis therapy.The transfer set was replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device evaluation was completed.The device was received attached to a titanium adapter for the reported condition.A visual inspection was performed with the naked eye which observed tool marks on the patient adapter indicating the patient adapter was manipulated by the user during use.Due to the condition of the patient adapter, the visual analysis was unable to determine any issues with the patient adapter.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Integrity testing was performed between patient adapter and the titanium adapter; there was no leak observed at the connection.There was slight difficulty removing the patient adapter from the titanium adapter due to the tool marks on the patient adapter, however, the two components were separated.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: 11065206
• MDR Text Key: 223430366
• Report Number: 1416980-2020-08005
• 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: 01/26/2021

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: H20D24032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TITANIUM ADAPTOR; TITANIUM ADAPTOR