MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC INTERLINK MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 1C8740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The actual device was not available; however, a photograph of the single-use device was provided for evaluation.Visual inspection revealed that the set has all components and does not have any damage.No signs of a leak 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.

Event Description

This report summarizes 1 malfunction events.It was reported that an interlink micro-volume extension set was leaking from an unspecified location.It was not specified if a patient was involved in the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: INTERLINK MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8280044
• MDR Text Key: 134339243
• Report Number: 1416980-2019-00273
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 00085412082028
• UDI-Public: (01)00085412082028
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1C8740
• Device Lot Number: DR18E21054
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1