NA 2N3347Recalls & reported problems
Baxter International Inc. · Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412004815), received between Oct 6, 2020 and Jun 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Prime” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Prime1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED. THE EVENTS OCCURRED DURING AN UNKNOWN PROCESS STEP IN THE NEONATAL ICU. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19617509 ↗MalfunctionOct 6, 2020Failure to Prime; Failure to Prime
IT WAS REPORTED A NON-DEHP MICRO-VOLUME EXTENSION SET WAS UNABLE TO PRIME. IT WAS FURTHER REPORTED, THE SET WAS DISCONNECTED FROM THE PRIMARY TUBING AND ATTEMPTED TO PRIME WITH A NORMAL SALINE FLUSH; HOWEVER, THE DEVICE WAS ¿MET WITH EXTREME RESISTANCE¿. THE ISSUE OCCURRED DURING PRIME; THEREFORE THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10638557 ↗
Other Filter, infusion line devices
- Medex MX20846R2Icu Medical, Inc. · Filter, infusion line1 recall0 reports
- NA 2N3350Baxter International Inc. · Filter, infusion line33 reports
- Medex FS116Icu Medical, Inc. · Filter, infusion line30 reports
- Medex MX448HFBIcu Medical, Inc. · Filter, infusion line27 reports
- INTERLINK 1C8740Baxter International Inc. · Filter, infusion line10 reports
- NA 2N3342Baxter International Inc. · Filter, infusion line8 reports
- FLUID SYSTEMS ACCESSORIES 2N3368Baxter Healthcare Corporation · Filter, infusion line5 reports
- Medex FS113Icu Medical, Inc. · Filter, infusion line3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.