Extension Set 473041Recalls & reported problems
B. Braun Medical Inc. · Small bore triple-leg extension set with no injection site · Class 2
All models of Extension Set (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04022495770202), received between Dec 10, 2018 and Jun 27, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Fluid/Blood Leak2
- Break1
- Crack1
- Improper Flow or Infusion1
- Material Puncture/Hole1
- Reflux within Device1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
- Hemodynamic instability1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: CHICKEN FOOT EXTENSION SET WITH VASOACTIVE MEDS RUNNING THROUGH IT, CRACKED, IN WHICH PATIENT'S HEMODYNAMICS BECAME UNSTABLE WHICH LED TO POST-OPERATIVE BLEEDING AND REQUIRED RETURN TO OR.
Patient problems: Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding
MAUDE report 22345418 ↗MalfunctionJun 27, 2025Crack; Leak/Splash; Reflux within Device; Crack; Leak/Splash; Reflux within Device
AS REPORTED BY THE USER FACILITY: DESCRIPTION: BEDSIDE RN DISCOVERED CRACK IN GREEN HUB OF BRAUN SMALLBORE TRIPLE-LEG EXTENSION SET. THIS EXTENSION SET WAS ATTACHED TO PATIENTS L FEM TRIPLE LUMEN CVC. AS A RESULT, BLOOD BACK FLOWED IN LUMEN AND THROUGH CRACK- PATIENT WAS NOT RECEIVING THE PRESSORS INFUSING THROUGH LINE AND SIMULTANEOUSLY BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22345244 ↗MalfunctionAug 12, 2021Leak/Splash; Improper Flow or Infusion; Leak/Splash; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: "WE HAVE NOTICED BLOOD BACKFLOW IN OUR IV LINES WHICH WAS FIXED BY RAISING DEPENDENT LINES AND RAISING PUMPS HIGHER BUT THIS ONE TIME, THERE WAS BLOOD LEAKAGE AND AIR IN LINE DUE TO A CRACK IN THE CARESITE". "NO INJURY TO THE INFANT DUE TO THE ISSUE. PRODUCT WAS REPLACED. THE BABY NEEDED ADDITIONAL LEVEL OF CARE AND WAS TRANSFERRED OUT DUE TO OTHER MEDICAL ISSUES. UNKNOWN OUTCOME."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315665 ↗MalfunctionMay 22, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: A LONGITUDINAL CRACK WAS FOUND ON THE FEMALE LUER, CAUSING MINIMAL BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8634006 ↗MalfunctionDec 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING USE THE EXTENSION SET LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: Blood Loss
MAUDE report 8148462 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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