MICRO-VOLUME 2N3348Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00085412004822), received between Mar 20, 2018 and Sep 25, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Crack; Fluid/Blood Leak

  It was reported that a Micro Volume Extension Set leaked while a saline flush was administered through a central venous catheter medication line. The set was broken near the cap at the connection between the medication line and the component that screws into the cap. 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 50899456 ↗
• MalfunctionSep 8, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672159 ↗
• MalfunctionMar 30, 2026Obstruction of Flow

  IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET COULD NOT BE FLUSHED WHEN STARTING A MEDICATION LINE. HEALTHCARE PROFESSIONAL REMOVED THE MICROCLAVE AND ATTEMPTED TO FLUSH THE LINE BY CONNECTING THE SYRINGE DIRECTLY; HOWEVER, THE LINE REMAINED NON-FLUSHABLE. THIS OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT. 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 24731760 ↗
• MalfunctionMar 11, 2026Failure to Prime; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A NON-DEHP MICRO-VOLUME EXTENSION SET. IT WAS OBSERVED THAT FLUIDS WERE NOT ABLE PASS THROUGH THE TUBING AND THE SET WOULD NOT PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572402 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP MICRO-VOLUME EXTENSION SET SEPARATED FROM THE LUER LOCK WHICH RESULTED IN A FLUID LEAK. THE LEAK WAS OBSERVED DURING USE OF THE DEVICE. 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 24448981 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AROUND THE LUER HUB. THE DEVICE WAS CONNECTED TO A SYRINGE. THIS WAS OBSERVED DURING SETUP. HERE 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 24448980 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) UNITS OF NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED DURING PATIENT INFUSION WITH PACKED RED BLOOD CELLS (PRBC'S). THE ISSUE WAS DESCRIBED AS FOLLOWS; A NEWLY INSERTED PARENTERAL INTRAVENOUS (PIV) LINE WAS FLUSHED WITH 3MLS OF SALINE BEFORE THE INFUSION BEGAN. FIFTEEN MINUTES AFTER STARTING THE TRANSFUSION, BLOOD WAS FOUND IN THE PATIENT¿S BED. THE INFUSION WAS PAUSED AND THE IV LINE WAS FLUSHED WITHOUT ANY ISSUE. THE UNSPECIFIED INFUSION PUMP DID NOT ALARM FOR OCCLUSION AS THE BLOOD WAS LEAKING FROM THE CONNECTION SITE. THE TUBING WAS REPLACED AND PRIMED. WHEN THE TRANSFUSION WAS RESTARTED, BLOOD LEAKED AGAIN FROM THE CONNECTION BETWEEN THE TUBING AND THE T PIECE. THE CONNECTION WAS TAKEN APART, CLEANED, AND RECONNECTED; HOWEVER, THE BLOOD CONTINUED TO LEAK. A THIRD TUBING WAS PRIMED WITH SALINE AND SHOWED NO ISSUES. HOWEVER, THE LEAK REOCCURRED ONCE THE TRANSFUSION RESUMED. THE TUBING WAS THEN REPLACED WITH A SET FROM A DIFFERENT LOT AND THE TRANSFUSION RAN SMOOTHLY WITH NO LEAKS AT THE PIV CONNECTION SITE. 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 24444828 ↗
• MalfunctionSep 5, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILE PACKAGING OF EIGHT (8) NON-DEHP MICRO-VOLUME EXTENSION SETS WERE DAMAGED. THE DAMAGE WAS DESCRIBED AS BRITTLE PACKAGING THAT CAN BE EASILY BROKEN APART WHEN GRABBED. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982609 ↗
• MalfunctionFeb 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE CONNECTION SITE BETWEEN THE SYRINGE AND EXTENSION TUBING. THE TUBING WAS TO BE CHANGED IMMEDIATELY. THIS OCCURRED DURING USE. 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 21350184 ↗
• 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 19617853 ↗
• MalfunctionNov 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP MICRO-VOLUME EXTENSION SET WAS FOUND IN HALF. THIS WAS IDENTIFIED AFTER OPENING THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192377 ↗
• MalfunctionAug 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE CONNECTOR OF A NON-DEHP MICRO-VOLUME EXTENSION SET CRACKED AND BROKE INTO AN UNSPECIFIED NEEDLELESS CONNECTOR. THIS WAS DESCRIBED AS ¿WHEN NURSE WAS ATTACHING MED TUBING TO NEEDLELESS CONNECTOR, THE TUBING CONNECTION CRACKED AND BROKE IN THE NEEDLELESS CONNECTOR¿. THIS ISSUE OCCURRED UPON CONNECTION TO A PATIENT WHO HAD BEEN ADMITTED TO THE "PCICU" (PEDIATRIC INTENSIVE CARE UNIT) POSTOPERATIVELY. 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 15234075 ↗
• MalfunctionJul 29, 2021Complete Blockage; No Flow; Complete Blockage; No Flow

  IT WAS REPORTED THAT TWO (2) NON-DEHP MICRO-VOLUME EXTENSION SETS WERE OCCLUDED. IT WAS FURTHER REPORTED THAT THE TUBING COULD NOT BE INJECTED WITH FLUID. THIS WAS OBSERVED AFTER TAKING OUT OF THE PACKAGE. 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 12249733 ↗
• MalfunctionJul 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET HAD VISIBLE BLACK MATERIAL IN THE LUER LOCK IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100726 ↗
• MalfunctionJan 30, 2020Partial Blockage; No Flow; Partial Blockage; No Flow

  IT WAS REPORTED THAT TWO (2) NON-DEHP MICRO-VOLUME EXTENSION SETS WOULD NOT FLUSH AS THOUGH THERE WAS AN OCCLUSION IN THE TUBING. THIS WAS IDENTIFIED WHILE ATTEMPTING TO SET UP AN INFUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9650166 ↗
• MalfunctionJan 15, 2020Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT THERE WAS "TROUBLE FLUSHING OUT THE LINE" OF A NON-DEHP MICRO-VOLUME EXTENSION SET. 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 Consequences Or Impact To Patient

  MAUDE report 9592988 ↗
• MalfunctionNov 1, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBE OF A MICRO-VOLUME RADIATION STERILIZED EXTENSION SET "CAME OFF FROM THE MALE LUER". THE SET WAS REPLACED WITH ANOTHER AND SET UP WAS COMPLETED. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9268462 ↗
• MalfunctionDec 21, 2018No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH A MICRO-VOLUME EXTENSION SET. THIS EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8190333 ↗
• MalfunctionNov 21, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET WAS HAVING CONNECTIVITY ISSUES WITH NEEDLESS TUBING CONNECTORS. THIS EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8097099 ↗
• MalfunctionMar 20, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE EXTENSION SET TUBING FELL APART DURING SET UP. THIS EVENT WAS FURTHER DESCRIBED AS THE END PIECE OF THE MICROBORE TUBING FALLING OFF. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7353140 ↗
• MalfunctionMar 20, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE EXTENSION SET TUBING FELL APART DURING SET UP. THIS EVENT WAS FURTHER DESCRIBED AS THE END PIECE OF THE MICROBORE TUBING FALLING OFF. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7353052 ↗