NA 2R1145Recalls & reported problems
Baxter International Inc. · Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412565620), received between Jul 8, 2022 and Jul 31, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak7
- Detachment of Device or Device Component2
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING OF A NON-DEHP IV FAT EMULSION ADMINISTRATION SET "BROKE OFF WHERE THE CONNECTION ON THE LINE WAS ATTACHED" (MALE LUER TO TUBING JUNCTION). THIS WAS OBSERVED 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 22683092 ↗MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN IV (INTRAVENOUS) FAT EMULSION ADMINISTRATION SET LEAKED FROM THE BOTTOM OF THE TUBE. THE LEAK OCCURRED 3 INCHES DOWN FROM WHERE THE TUBE STARTS. 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 19599842 ↗MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP IV FAT EMULSION ADMINISTRATION SET WAS LEAKING AT THE PORT. THE 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 16871712 ↗MalfunctionMar 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING OF A NON-DEHP IV FAT EMULSION ADMINISTRATION SET LEAKED BELOW THE DRIP CHAMBER. THIS WAS IDENTIFIED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16573174 ↗MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP IV FAT EMULSION ADMINISTRATION SET LEAKED FROM THE DRIP CHAMBER. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16488943 ↗MalfunctionJan 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LINE OF A NON-DEHP IV FAT EMULSION ADMINISTRATION SET LEAKED. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 16246499 ↗MalfunctionOct 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A NON-DEHP IV FAT EMULSION ADMINISTRATION SET LEAKED BETWEEN DRIP CHAMBER AND TUBING. THIS ISSUE WAS IDENTIFIED 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 15565474 ↗MalfunctionJul 22, 2022Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT THREE (3) NON-DEHP IV FAT EMULSION ADMINISTRATION SETS HAD DAMAGED LINES. THIS WAS FURTHER DESCRIBED AS: TWO (2) OF THE LINES WERE CUT IN TWO AND SEPARATED NEAR THE FILTER AND ONE (1) HAD A SPLIT IN THE MIDDLE LENGTH WISE. THIS WAS IDENTIFIED BEFORE USE; PRIOR TO INFUSION AND NOTICED WHILE STILL IN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15085962 ↗MalfunctionJul 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING OF A NON-DEHP IV FAT EMULSION ADMINISTRATION SET LEAKED AT THE TOP OF THE LINE WHERE IT CONNECTS TO THE IV BAG. THIS ISSUE WAS IDENTIFIED DURING 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 14959779 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.