NA 2N3349Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412004839), received between Nov 16, 2018 and Jan 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) CONTAMINATION WITHIN A NON-DEHP HIGH FLOW RATE EXTENSION SET. THE PM WAS DESCRIBED AS BROWN FLECKS INSIDE THE IV FLUID PATH (IN THE TUBING). IT IS UNKNOWN WHETHER THE PARTICULATE WAS LOOSE OR EMBEDDED. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED DURING THIS EVENT. 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 24178195 ↗
• MalfunctionJan 20, 2026Improper Flow or Infusion; Material Deformation

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF NON-DEHP HIGH FLOW RATE EXTENSION SETS DISTENDED WHICH RESULTED IN VARIABLE FLOW RATES WHEN USING WITH AN UNSPECIFIED SYRINGE PUMP. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN AND WAS UNKNOWN IF A PATIENT WAS CONNECTED DURING THIS EVENT. 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 24116178 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Material Puncture/Hole; Obstruction of Flow; Fluid/Blood Leak; Material Puncture/Hole; Obstruction of Flow

  IT WAS REPORTED THAT A NON-DEHP HIGH FLOW RATE EXTENSION SET WAS LEAKING FROM A HOLE IN THE TUBING WHICH RESULTED IN THE LINE LUMEN CLOTTING OFF. DURING A FENTANYL DRIP, IT WAS OBSERVED THAT THERE WAS A LEAK FROM A HOLE IN THE TUBING. THE PATIENT DID NOT RECEIVE THE DRUG AND THE LINE LUMEN CLOTTED OFF. THE ISSUE OCCURRED DURING PATIENT USE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. 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 23503380 ↗
• MalfunctionFeb 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP HIGH FLOW RATE EXTENSION SET WAS CRACKED RESULTING IN A LEAK. THIS WAS OBSERVED DURING PRIMING OF THE TUBING WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720435 ↗
• MalfunctionMar 15, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP HIGH FLOW RATE EXTENSION SET HAD A SMALL CRACK WHICH LED TO A MEDICATION LEAK. THIS 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 11487865 ↗
• MalfunctionAug 28, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP HIGH FLOW RATE EXTENSION SET WAS LEAKING FROM THE DISTAL END JUNCTION DURING A PATIENT INFUSION. THIS WAS FURTHER DESCRIBED AS ¿THE ALBUMIN WAS HUNG ON NEW, PRIMED TUBING. WHEN INFUSION WAS COMPLETE THERE WAS A PUDDLE ON THE FLOOR¿. THE LEAK WAS NOTED TO BE AT THE HUB BUT NO OBVIOUS DAMAGE. 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 10468744 ↗
• MalfunctionSep 9, 2019Disconnection; Disconnection

  IT WAS REPORTED TWO (2) RADIATION STERILIZED EXTENSION SETS DISCONNECTED EASILY. IT WAS FURTHER SPECIFIED THAT THE FEMALE END WOULD "PULL AWAY" FROM THE MALE ADAPTER; THE FEMALE END SHOULD LUER-LOCK ONTO THE NON-BAXTER CAP OR TO THE INTRAVENOUS (IV) TUBING. THIS WAS IDENTIFIED DURING PATIENT USE. 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 8976307 ↗
• MalfunctionAug 5, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT SIX (6) NON-DEHP HIGH FLOW RATE EXTENSION SETS LEAKED DURING PATIENT USE. IT WAS FURTHER REPORTED THAT TWO (2) OF THE SIX (6) SETS "BROKE COMPLETELY OFF FROM THE CONNECTION SIGHT". THE OTHER FOUR (4) LEAKS WERE NOT FURTHER SPECIFIED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861592 ↗
• MalfunctionNov 16, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT A HIGH FLOW RATE EXTENSION SET CAME APART AT THE LEUR LOCK. THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8078262 ↗