ULTRASITE® 474921Recalls & reported problems
B. Braun Medical Inc. · Small Bore Extension Set with Bonded ULTRASITE® Valve - Priming Volume: 0.6 mL Length: 9 in. · 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 04046964185748), received between Sep 5, 2018 and Oct 17, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Leak/Splash1
Patient problems
- Blood Loss2
- Exposure to Body Fluids2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: THE DEVICE WAS NOT COMPLETELY SEALED CAUSING SOME BLEEDING. THE PATIENT WAS IN A PAPOOSE POSITION WITH THEIR ARMS TUCKED SO THE ISSUE WAS NOT NOTED UNTIL THE PATIENT POSITIONING THE PATIENT IN SURGERY. AS SUCH THE PATIENT DID NOT GET THE ENTIRE DOSE OF PROPOFOL. THERE WAS DELIVERY ENOUGH TO STILL ANESTHETIZE PROPERLY AND GET GAS ON THE PATIENT. BACK IN THE PACU (POST ANESTHESIA CARE UNIT) THE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17948497 ↗MalfunctionMay 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: NURSES ARE CONTINUALLY HAVING ISSUES WITH BLOOD FOAMING WHEN DRAWN THROUGH THE SET. A NURSE WAS DISPOSING OF THE EXTENSION SET IN A SHARPS CONTAINER WHEN SHE GOT SQUIRTED BY BLOOD FROM THE SET IN THE FACE, INCLUDING THE EYES. HOSPITAL EXPOSURE PROTOCOL WAS FOLLOWED.
Patient problems: Exposure to Body Fluids
MAUDE report 8629121 ↗MalfunctionMay 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: NURSES ARE CONTINUALLY HAVING ISSUES WITH BLOOD FOAMING WHEN DRAWN THROUGH THE SET. A NURSE WAS DISPOSING OF THE EXTENSION SET IN A SHARPS CONTAINER WHEN SHE GOT SQUIRTED BY BLOOD FROM THE SET IN THE FACE, INCLUDING THE EYES. HOSPITAL EXPOSURE PROTOCOL WAS FOLLOWED.
Patient problems: Exposure to Body Fluids
MAUDE report 8629120 ↗MalfunctionNov 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE EXTENSION SET WAS CRACKED AT THE HUB WHICH CAUSED LEAKAGE OF A SCANT AMOUNT OF BLOOD AT THE CONNECTION. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 8117664 ↗MalfunctionSep 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE LUER ENDING OF THE IV ADMINSTRATION SET DETACHED FROM THE PATIENT'S IV CATHETER HUB WHICH RESULTED IN BLOOD LEAKAGE. NO INJURIES WERE REPORTED.
Patient problems: Blood Loss
MAUDE report 7846041 ↗
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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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