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

Catalog Number	1C8740
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• MDR Report Key: 8280044
• Report Number: 1416980-2019-00273
• Device Sequence Number: 18871698
• Product Code: FPB
• UDI-Device Identifier: 00085412082028
• UDI-Public: (01)00085412082028
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 1C8740
• Device Lot Number: DR18E21054
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1