ULTRASITE® 470021Recalls & reported problems
B. Braun Medical Inc. · Small Bore Y-extension Set with Two Bonded ULTRASITE® Valves · Class 2
All models of ULTRASITE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964183850), received between Dec 2, 2016 and Dec 5, 2020 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 4: BLOOD LEAKAGE WAS REPORTED. AS REPORTED BY THE USER FACILITY: "LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE EXT SET MALE SPIN LOCK CONNECTOR AND THE IV SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10950814 ↗MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: BLOOD LEAKAGE WAS REPORTED. AS REPORTED BY THE USER FACILITY: "LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE EXT SET MALE SPIN LOCK CONNECTOR AND THE IV SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10950798 ↗MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 3: BLOOD LEAKAGE WAS REPORTED. AS REPORTED BY THE USER FACILITY: "LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE EXT SET MALE SPIN LOCK CONNECTOR AND THE IV SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10950767 ↗MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: BLOOD LEAKAGE WAS REPORTED. AS REPORTED BY THE USER FACILITY: "LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE EXT SET MALE SPIN LOCK CONNECTOR AND THE IV SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10950708 ↗MalfunctionDec 2, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: CHEMO LEAKED FROM EXTENSION SET AT JUNCTION OF TUBING GOING INTO VALVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6140651 ↗
Other Set, administration, intravascular devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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