Extension Set 471960Recalls & reported problems
B. Braun Medical Inc. · Small bore 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04022495770127), received between Dec 14, 2018 and Mar 24, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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/Splash2
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- Pressure Sore/Ulcer1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING EXT SET. DETAILED INQUIRY DESCRIPTION: WHEN FLUSHED OR INFUSING, LEAKS WHERE CONNECTED TO T-CONNECTOR. UPON GIVING BEDSIDE REPORT ON (B)(6) 2025 AT 07:30 IT WAS NOTED THAT THERE WAS A SMALL DAMP SPOT ON PATIENT BLANKET. A SMALL AMOUNT OF BLOOD WAS NOTED IN THE T-CONNECTOR. BLANKET WAS NOT STICKY, BUT DECISION MADE BY NIGHT AND DAY SHIFT NURSE TO FLUSH IV. PATIENT DID NOT APPEAR TO HAVE ANY OTHER SOURCE FOR WETNESS AT THE TIME (WRONG LOCATION FOR DROOL OR EMESIS OR OG TUBE ASPIRATE). UPON FLUSHING IV, FLUID SPURTED OUT OF A TINY CRACK IN THE GREEN HUB COLORED T-CONNECTOR. IV WAS TAKEN DOWN TO THE YELLOW HUB. ASEPTIC TECHNIQUE USED. NEW T-CONNECTOR ATTACHED. IV SECURED WITH NEW TEGADERM AND TAPE. PIV FLUSHED WITHOUT DIFFICULTY. PIV INFUSION OF D10% CONTINUED WITHOUT DELAY. IMMEDIATELY PLACED FAULTY T-CONNECTOR IN TO A BAG WITH FLUSH ATTACHED. PIV HAD BEEN PLACED THE DAY BEFORE AND PACKAGING FOR T-CONNECTOR WAS UNABLE TO BE LOCATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21678997 ↗MalfunctionApr 11, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DESCRIPTION: SET IS LEAKING BLOOD. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712258 ↗InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS PER MEDWATCH (B)(4): EVENT DESCRIPTION: PERIPHERAL INTRAVENOUS (PIV) HUB WAS TAPED TO PATIENT PER STANDARDS OF CARE. AN UNSTAGEABLE INJURY WAS NOTED UNDER THE GAUZE WHICH WAS PADDING THE IV HUB WHICH WAS CAUSED BY THE FLANGES ON THE PIV HUB.
Patient problems: Pressure Sore/Ulcer
MAUDE report 14140375 ↗MalfunctionDec 14, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE EXTENSION SET WAS CRACKED AT THE FEMALE LUER WHICH CAUSED LEAKAGE. PACK RED BLOOD CELLS (PRBC) WERE INFUSING WHEN THE LEAK WAS OBSERVED. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8166563 ↗
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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