MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3374
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an interlink system non-dehp i.V.Catheter extension set was leaking between the male luer connection and a non-baxter filter.This event was discovered during an unspecified process step and it was unknown if there was patient involvement.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak and pressure tests were performed and revealed a leak from between the female luer lock adapter and the interlink.Further inspection of the female luer lock adapter revealed flash on the top surface area of the thread.The flash affected the sealing between the female luer lock adapter and the interlink, causing a channel leak between the parts.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.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: INTERLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9700301
• Report Number: 1416980-2020-00614
• Device Sequence Number: 13888936
• Product Code: FPA
• UDI-Device Identifier: 00085412004907
• UDI-Public: (01)00085412004907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K925126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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
• Operator of Device: Other
• Device Catalogue Number: 2N3374
• Device Lot Number: UR18F26127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-BAXTER FILTER; NON-BAXTER FILTER