NA 2N3350Recalls & reported problems
Baxter International Inc. · Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter · Class 2
Quick summary
This Baxter Micro-Volume extension set is a short tubing line with a built-in 0.2 micron filter used for drug infusions. The 32 reports mostly describe fluid or blood leaking from the line — often at the air vent or through a cracked filter — plus lines that would not flush, tubing that cracked, and filter alarms on Baxter pumps. No deaths and no injuries were reported, and reports rose from 4 to 9 over the past 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00085412004846), received between Mar 23, 2018 and Sep 1, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (26 reports).
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
- Fluid/Blood Leak26
- Crack6
- No Flow3
- Failure to Prime2
- Protective Measures Problem2
- Backflow1
- Break1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534744 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
It was reported that an unspecified quantity of Micro-Volume Extension Sets intermittently leaked through the air vent filter. The reporter stated that it was a continuous leakage.The process step at which the issue occurred was not specified. There was no report of patient injury or medical intervention associated with these events. No additional information is available at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50528289 ↗MalfunctionJun 5, 2026Device-Device Incompatibility; No Flow; Protective Measures Problem
IT WAS REPORTED THAT UNSPECIFIED UNITS OF NON DEHP MICRO VOLUME EXTENSION SETS CAUSED DOWNSTREAM OCCLUSION ALARMS ON THE BAXTER PUMP. THE TUBING WAS INSPECTED FOR UNCLAMPED CLAMPS AND KINKS; NO ISSUES WERE IDENTIFIED. THE PUMP WAS RESTARTED; HOWEVER, STILL OBSERVED DOWNSTREAM OCCLUSION ALARMS. IT WAS SUBSEQUENTLY DETERMINED THAT THE 0.2 MICRON FILTER WAS NOT COMPATIBLE WITH THE PUMP. A NEW BAG OF PACLITAXEL WAS PREPARED WITH A DIFFERENT 0.2 MICRON FILTER, AFTER WHICH THE PUMP FUNCTIONED WITHOUT OCCLUSION ALARMS. THE PREVIOUS DAY, SIMILAR OCCLUSION ALARMS OCCURRED DURING PACLITAXEL ADMINISTRATION WHEN THE SAME FILTER WAS CONNECTED TO THE SHORT SET. THE FILTER WAS REMOVED AND REPOSITIONED ON THE FLUSH LINE CLOSER TO THE PATIENT AND THE INFUSION CONTINUED WITHOUT ISSUES. 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 25410845 ↗MalfunctionMar 4, 2026Failure to Prime; No Flow
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF MICRO-VOLUME EXTENSION SETS WERE UNABLE TO BE FLUSHED. THIS WAS OBSERVED SETUP. 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 24512148 ↗MalfunctionMar 4, 2026Fluid/Blood Leak; Failure to Prime
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF MICRO-VOLUME EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING SETUP. 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 24506317 ↗MalfunctionJan 8, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. THIS WAS OBSERVED DURING SETUP. THE DEVICE CONTAINED BENADRYL AND NORMAL SALINE. 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 24016591 ↗MalfunctionJan 5, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED FROM A CRACKED FILTER. THIS WAS OBSERVED WHILE RUNNING ANTIBIOTIC. THE LINE WAS CHANGED MIDWAY. 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 23968894 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT THE MEDIPORT NEEDLE OF A MICRO-VOLUME EXTENSION SET BROKE DURING PATIENT INFUSION. THE DEVICE CONTAINED IVF AND MESNA. 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 23576825 ↗MalfunctionNov 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED FROM THE AIR VENT. THE ISSUE OCCURRED AFTER PRIMING. THE DEVICE WAS ATTACHED TO A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). 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 23546248 ↗MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED FROM THE AIR-VENT. THE ISSUE OCCURRED AFTER PRIMING. THE DEVICE WAS ATTACHED TO A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). 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 23538903 ↗MalfunctionOct 21, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED FROM A CRACK IN THE FILTER. THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348095 ↗MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED THROUGH THE AIR VENT HOLE. THE ISSUE OCCURRED WHEN THE LINE WAS PRIMED USING A PUMP OR MANUALLY WHEN THEY ARE CHANGING MEDICATIONS(IN PARTICULAR, SEDATION/ANALGESIA) OR FLUSHES. 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 22480809 ↗MalfunctionMay 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) MICRO-VOLUME EXTENSION SETS LEAKED AT THE FILTER PRIOR TO THERAPY. A SYRINGE WAS USED TO PRIME THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047194 ↗MalfunctionJan 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER DURING USE. THE FILTER WAS LEAKING EVEN WHEN MANUALLY FLUSHED. THE DEVICE CONTAINED FAMOTIDINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178508 ↗MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS LEAKED FROM THE FILTER. THE LEAK OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 20214505 ↗MalfunctionSep 10, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT WERE FLOW ISSUES THROUGH AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS. THERE WERE OCCLUSIONS WHICH RESULTED IN DIFFICULTIES WITH FLUSHING LIPIDS THROUGH. THIS OCCURRED DURING PATIENT INFUSION. 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 20185528 ↗MalfunctionSep 10, 2024Backflow; Backflow
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET HAD LIPIDS BACKING UP IN THE TUBING. THE BACKFLOW WAS CAUSING THE OCCLUSION LIMIT TO GO OFF ON THE PUMP. THIS OCCURRED DURING INFUSION. 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 20180310 ↗MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED FROM THE FILTER. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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 18597249 ↗MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED FROM THE FILTER. THE SET WAS CONNECTED TO AN UPPER EXTREMITY PEDIATRIC PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE. 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 18596799 ↗MalfunctionJan 29, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET WAS CRACKED AND LEAKED AT THE CIRCULAR FILTER OF THE LINE CONNECTED TO THE INTERNAL JUGULAR CATHETER PORT. NO OTHER MEDICATIONS WERE RUNNING THROUGH THE PORT DUE TO ACCESS AVAILABILITY FOR DRIPS AND ALPROSTADIL AND TPN (TOTAL PARENTERAL NUTRITION) LIPIDS. 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 18596170 ↗MalfunctionDec 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. THIS OCCURRED DURING PATIENT INFUSION. 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 18372747 ↗MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. THIS OCCURRED DURING PATIENT INFUSION. 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 18345589 ↗MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED. THIS ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. 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 17916027 ↗MalfunctionOct 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED AROUND THE FILTERED AREA. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 17875966 ↗MalfunctionAug 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE FILTER OF A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 17605927 ↗
Other Filter, infusion line devices
- Medex MX20846R2Icu Medical, Inc. · Filter, infusion line1 recall0 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
- NA 2N3347Baxter International Inc. · Filter, infusion line2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.