NA 2N3342Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00085412004778), received between Dec 20, 2018 and Nov 4, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NON-DEHP THREE LEAD EXTENSION SET WAS CUT OFF AT DISTAL TO CIRCLE FILTER. THE ISSUE WAS NOTICED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466658 ↗
• MalfunctionJan 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP THREE LEAD EXTENSION SET LEAKED FROM THE MICROBORE FILTER. THIS WAS OBSERVED UPON INSPECTION DURING PATIENT INFUSION. THE FLUID HAD BEEN INFUSING FOR APPROXIMATELY 12 HOURS, AND THE LEAK WAS DISCOVERED DUE TO WET SHEETS. 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 21104116 ↗
• MalfunctionJul 1, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ¿PIG TAIL¿ OF A NON-DEHP THREE LEAD EXTENSION SET APPEARED CRACKED RESULTING IN A LEAK. 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 12103347 ↗
• MalfunctionSep 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE TRI-FURCATED FILTERS OF TWO (2) NON-DEHP THREE LEAD EXTENSION SETS WERE DISCOLORED. IT WAS FURTHER REPORTED THAT THERE WAS BROWN SEDIMENT OBSERVED IN THE FILTERS. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSIONS. THE SETS WERE BEING USED ON TPN LINES (TOTAL PARENTERAL NUTRITION). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583174 ↗
• MalfunctionJul 30, 2020Obstruction of Flow; Obstruction of Flow

  DURING EVALUATION OF A NON-DEHP THREE LEAD EXTENSION SET, THE FILTER WAS FOUND BLOCKED RESULTING IN ABNORMAL FLOW. 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 10344854 ↗
• MalfunctionOct 7, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP THREE LEAD EXTENSION SET HAD A HOLE WHICH CAUSED A LEAK. IT WAS FURTHER REPORTED THAT THE HOLE WAS LOCATED BETWEEN THE UPPER TWO BRANCHES OF TUBING AND THE LOWER BRANCH, IN A PORTION OF THE TUBING WITH NO SLIDE CLAMP. THE ISSUE WAS IDENTIFIED DURING USE ON A BABY IN THE NICU (NEONATAL INTENSIVE CARE UNIT). IT WAS REPORTED THAT THE PATIENT WAS ALREADY ON UNSPECIFIED ANTIBIOTICS AT THE TIME OF THE EVENT. THE SET WAS IN USE TO DELIVER TOTAL PARENTAL NUTRITION (TPN) TO THE PATIENT. 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 9162099 ↗
• MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED DURING INFUSION. THE EVENT INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8287444 ↗
• MalfunctionDec 20, 2018Fluid/Blood Leak

  DURING THE INFUSION OF TPN PRODUCT IN THE NICU IT WAS NOTICED THE TUBING WAS LEAKING ON THE THIRD DAY. THE LEAKING WAS NOT IN THE CONNECTIVE PART OF THE TUBING. THE TUBING WAS DUE TO BE CHANGED THAT DAY. THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO OTHER MEDICAL FOLLOW-UP NECESSARY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8183985 ↗