EXTENSION SET 2N3354Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412638836), received between May 27, 2025 and May 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THE EVENT OCCURRED AT THE NICU DEPARTMENT. 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 25305821 ↗
• MalfunctionMay 18, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS OBSERVED IN A MICRO-VOLUME EXTENSION SET CONNECTED TO A BAXTER LIPID FILTER. THE ISSUE WAS IDENTIFIED WHILE THE REGISTERED NURSE WAS PRIMING THE LINE ON THE INFUSION PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210851 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE CONNECTION WITH A BAXTER LIPID FILTER. PATIENT WAS CONNECTED DURING THE 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 25210588 ↗
• MalfunctionJan 8, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET HAD A CRACK NEAR THE CONNECTION TO A NON-BAXTER NEEDLELESS CONNECTOR RESULTING IN A MEDICATION LEAK. THE ISSUE WAS FURTHER DESCRIBED AS "THE SYRINGE LINE ON THE RED LUMEN WAS FOUND TO BE CRACKED AND LEAKING". THIS WAS OBSERVED WHEN FLUSHING THE SET. THE SYRINGE LINE (SET) 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 24011144 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING PATIENT INFUSION WITH A CYCLOSPORINE SYRINGE MEDICATION. 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 22834510 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET APPEARED TO BE LEAKING FROM THE CAP. WHILE INFUSING CICLOSPORINE THROUGH A CENTRAL LINE, THE CICLOSPORINE SYRINGE LINE STARTED LEAKING FROM 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 22828407 ↗
• MalfunctionJul 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET APPEARED TO BE LEAKING FROM THE CAP. WHILE INFUSING CICLOSPORINE THROUGH A CENTRAL LINE, THE CICLOSPORINE SYRINGE LINE STARTED LEAKING FROM 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 22631390 ↗
• MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION; CONNECTIONS WERE ALL TIGHT. CYCLOSPORINE MEDICATION WAS ADMINISTERED DURING PATIENT INFUSION. THE SYRINGE LINE WAS CHANGED TO RESOLVE THE ISSUE; NO FURTHER LEAKS OBSERVED. 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 22621025 ↗
• MalfunctionJul 25, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET HAD A CRACK RESULTING IN A LEAK NEAR THE CONNECTION POINT TO A NON-BAXTER CONNECTOR. THIS WAS OBSERVED DURING DEVICE USE, WHEN HANGING A FLUSH FOR MEDICATION (PIPERACILLIN/TAZOBACTAM). IT WAS FURTHER DESCRIBED AS "CRACK AT TOP OF SYRINGE LINE WHERE WE ATTACH A 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 22610235 ↗
• MalfunctionMay 27, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET HAD A CRACK ON THE LINE LOCATED BEFORE THE LUMEN ATTACHMENT SITE, WHICH RESULTED IN LEAKAGE. THIS OCCURRED DURING PATIENT INFUSION WITH VANCOMYCIN MEDICATION. UPON RETURNING TO FLUSH THE LINE, CONDENSATION WAS OBSERVED ON THE LINE AND THERE WAS FLUID ON THE FLOOR. 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 22089653 ↗