INTERLINK MICRO-VOLUME EXTENSION SET 1C8740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for INTERLINK MICRO-VOLUME EXTENSION SET 1C8740 manufactured by Baxter Healthcare - Dominican Republic.

Event Text Entries

[134339243] 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.
Patient Sequence No: 1, Text Type: N, H10

[134339244] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-00273
• MDR Report Key: 8280044
• Date Received: 2019-01-25
• Date of Report: 2019-01-25
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2019-01-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE - DOMINICAN REPUBLIC
• Manufacturer Street: CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA
• Manufacturer City: HAINA SAN CRISTOBAL
• Manufacturer Country: DR
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: INTERLINK MICRO-VOLUME EXTENSION SET
• Generic Name: FILTER, INFUSION LINE
• Product Code: FPB
• Date Received: 2019-01-25
• Model Number: NA
• Catalog Number: 1C8740
• Lot Number: DR18E21054
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE - DOMINICAN REPUBLIC
• Manufacturer Address: HAINA SAN CRISTOBAL

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-25