NA 2C5645Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00085412001814), received between Sep 16, 2019 and Apr 16, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) EXTENSION SETS, WHEN CONNECTED, EXHIBIT FLUID LEAKAGE. THE ISSUE WAS DETECTED BEFORE USE AT THE PATIENT¿S HOME. 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 24901419 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) IN AN EXTENSION SET LUER LOCK ADAPTER. THE PM WAS DESCRIBED AS HAIR INSIDE THE PRODUCT. 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 23882474 ↗
• MalfunctionNov 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN EXTENSION SET, MALE LUER LOCK ADAPTER WAS INCORRECTLY ASSEMBLED. THIS ISSUE WAS DESCRIBED AS, ¿DEVICE EXHIBITED A DEFECT AT THE TIPS, WHICH WERE MANUFACTURED IDENTICALLY¿. THIS ISSUE WAS DETECTED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649815 ↗
• MalfunctionNov 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PACKAGING OF AN EXTENSION SET WAS STAINED. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611642 ↗
• MalfunctionOct 15, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT TWO (2) EXTENSION SETS HAD ILLEGIBLE TEXT. THIS WAS OBSERVED DURING STORAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293790 ↗
• MalfunctionOct 15, 2025Backflow; Incomplete or Inadequate Connection; Backflow; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A PATIENT IN THE INTENSIVE CARE UNIT ARRIVED WITH AN EXTENSION SET IN WHICH THE ADAPTER WOULD NOT ALLOW PROPER CLOSURE OF THE STOPCOCK WHICH RESULTED IN A BACKFLOW. THIS ISSUE OCCURRED DURING USE OF AN ANESTHESIA EXTENSION SET WITH A PATIENT. 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 23286633 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THREE (3) EXTENSION SETS RUPTURED DURING INJECTION OF THE CONTRAST MEDIUM. A INJECTOR WAS USED FOR ADMINISTERING THE CONTRAST. 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 22560921 ↗
• MalfunctionApr 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTENSION SET LEAKED FROM THE LUER LOCK CONNECTOR. THIS OCCURRED 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 21867276 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT AT LEAST NINE (9) EXTENSION SETS BROKE DUE TO LIQUID PRESSURE IN THE PRE-INJECTION PHASE. 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 21044408 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT AN EXTENSION SET BROKE DUE TO LIQUID PRESSURE IN THE PRE-INJECTION PHASE. 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 21044395 ↗
• MalfunctionSep 16, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT TWO (2) EXTENSION SETS DISCONNECTED FROM A NON-BAXTER INTRAVENOUS (IV) ADMINISTRATION SET. THE DISCONNECTIONS OCCURRED DURING ADMINISTRATION OF ANESTHESIA DURING SURGERY. 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 9070461 ↗