NA 2N1191Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00085412004532), received between Aug 24, 2018 and Aug 5, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142598 ↗
• MalfunctionJun 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS SEPARATED FROM THE "HUB". THE REPORTER DESCRIBED THE ISSUE AS "Y-SITES THAT COULD BE PULLED APART EASILY" AND "UNITS WERE FOUND TO EASILY PULL APART AT THE HUB". THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564124 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED "AT THE FIRST CONNECTION TO THE TUBING." THE EVENT OCCURRED DURING 0.9% SODIUM CHLORIDE FLUSH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772609 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS WERE LEAKING FROM WHERE THE LUER LOCK ATTACHES TO THE TUBING. SOME LEAKS OCCURRED DURING INITIAL PRIMING AND SOME LEAKS OCCURRED DURING INFUSION WHILE THE PATIENT WAS CONNECTED FOR THERAPY. 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 24563873 ↗
• MalfunctionFeb 20, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET HAD A BROKEN Y SITE. THE BIFUSE BROKE AT THE DISTAL PART OF THE Y ON ITS OWN WITHOUT BEING PULLED OR UNDUE PRESSURE APPLIED. THIS OCCURRED DURING PATIENT INFUSION WITH TOTAL PARENTERAL NUTRITION/INTRALIPID (TPN/IL). 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 24402187 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED AT THE INSERTION END OF THE CATHETER, CLOSEST TO THE PATIENT. THIS WAS OBSERVED DURING PRIMING AT A HIGHER RATE (LESS THAN 999 ML/HOUR). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936257 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A Y-TYPE CATHETER EXTENSION SET LEAKED AT THE CONNECTION SITE BETWEEN THE LINE AND THE END CONNECTOR. THIS WAS OBSERVED WHEN THE PUMP STARTED. THE DEVICE CONTAINED IMMUNOTHERAPY. 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 23699863 ↗
• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED AT THE CONNECTION SITE BETWEEN THE LINE AND THE END CONNECTOR. THE ISSUE OCCURRED WHEN DRUG WAS RUNNING, 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 23536285 ↗
• MalfunctionOct 28, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE CATHETER EXTENSION SET LEAKED FROM A TINY CRACK AT TOP OF SEAL BEFORE THE CATHETER BIFURCATES. THIS WAS OBSERVED AT THE INITIATION OF THE INFUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407424 ↗
• MalfunctionOct 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET WAS LEAKING AT THE CONNECTION TO THE Y PORTION. THE LEAK WAS OBSERVED AS SOON AS THE PUMP WAS STARTED. THE PATIENT WAS CONNECTED AT THE TIME OF 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 23343334 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF NON-DEHP Y-TYPE CATHETER EXTENSION SETS LEAKED FROM UNSPECIFIED LOCATION 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 21531789 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED FROM UNSPECIFIED LOCATION 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 21518369 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED FROM UNSPECIFIED LOCATION 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 21518365 ↗
• MalfunctionMay 23, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPRTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED. THE UMBILICAL VENOUS CATHETER (UVC) WAS BACKFLOWING WITH BLOOD FROM THE CRACK ON THE BIFUSE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19384659 ↗
• MalfunctionMay 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED. THE EVENT WAS FURTHER DESCRIBED AS; DURING INFUSION, "CYTOTOXIC MEDICATION LEAKAGE ONTO A PATIENTS CLOTHING". THE CYTOTOXIC MEDICATION WAS DOCETAXEL. 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 14429941 ↗
• MalfunctionJun 22, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT TWO (2) NON-DEHP Y-TYPE CATHETER EXTENSION SETS BROKE (ONE TUBING SEPARATED FROM THE MALE LUER AND ONE TUBING SEPARATED FROM THE Y-JUNCTION). THIS WAS IDENTIFIED DURING PATIENT USE. THE SETS WERE CONNECTED TO TPN (TOTAL PARENTERAL NUTRITION)/LIPIDS AND WERE REPLACED TO CONTINUE THERAPY. 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 10179620 ↗
• InjuryApr 28, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A PEDIATRIC PATIENT EXPERIENCED A BLOOD LOSS DURING AN OVERNIGHT INFUSION OF INTRALIPIDS AND TOTAL PARENTERAL NUTRITION USING A Y-TYPE CATHETER EXTENSION SET. THE CAREGIVER REPORTED THE TUBING WAS NOT CUT OR SLICED, HOWEVER, ¿APPEARED TO HAVE BROKEN¿. THE CAREGIVER NOTED IT WAS UNKNOWN HOW LONG THE PUMP WAS NOT INFUSING AS THE EVENT OCCURRED OVERNIGHT WHILE THE PATIENT WAS SLEEPING. THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 10005757 ↗
• MalfunctionSep 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP Y-TYPE CATHETER EXTENSION SET LEAKED WHILE DRAWING BLOOD. IT WAS FURTHER REPORTED THAT THE UNSPECIFIED VOLUME OF BLOOD WAS LEAKING COMING FROM THE Y-CONNECTOR. 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 9105964 ↗
• MalfunctionAug 24, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A Y-TYPE CATHETER EXTENSION SET SEPARATED AND LEAKED WHILE IN USE ON A PATIENT. THE SET WAS BEING USED TO DELIVER TPN (TOTAL PARENTERAL NUTRITION) AND LIPIDS. IT WAS REPORTED THAT THE SET WAS INSPECTED BY TWO NURSES AND PRIMED WITH TPN AND LIPIDS PRIOR TO USE ON THE PATIENT. THE SET WAS INSPECTED AGAIN WHEN THE INFUSION WAS INITIATED (2235) AND EVERY HOUR UNTIL 0520 ON THE FOLLOWING DAY WHEN THE LINE WAS NOTED TO BE ¿SNAPPED¿ (SEPARATED). THE TUBING SEPARATION OCCURRED AT THE BOTTOM OF THE Y-SITE WHERE IT CONNECTS TO THE MALE LUER. 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 7814049 ↗