INTERLINK MICRO-VOLUME EXTENSION SET
Received Dec 13, 2023 · Event occurred Nov 7, 2023
Report 1416980-2023-06480 · MDR key 18317935
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3333
Lot number
DR23A13055
Product problems
- No Flow
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET. THEY FLUSH NEW SOLUTION FOR IV ADMINISTRATION AND NOTED NO FLUSH. REMOVED THE TUBING AND TRIED JUST THE EXTENSION PIECE BUT STILL NO FLUSH. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED TO H6 AND H10. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.