ULTRASITE® 473447Recalls & reported problems
B. Braun Medical Inc. · Standard Bore extension Set with Bonded ULTRASITE® Valve · 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 04046964185342), received between Mar 14, 2019 and Oct 19, 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 Conditions3
- Blood Loss1
- 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.
MalfunctionOct 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE CUSTOMER IS COMPLAINING OF EXTENSION SET LEAKAGE OF FLUID AND BLOOD. IN SOME INSTANCES AT BOTH THE MALE LUER CONNECTOR, AND OTHERS AT THE JUNCTION OF THE ULTRASITE CONNECTION TO THE EXTENSION SET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10699143 ↗MalfunctionOct 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY, "THE CUSTOMER IS COMPLAINING OF EXTENSION SET LEAKAGE OF FLUID AND BLOOD. IN SOME INSTANCES AT BOTH THE MALE LUER CONNECTOR, AND OTHERS AT THE JUNCTION OF THE ULTRA-SITE CONNECTION TO THE EXTENSION SET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10699125 ↗MalfunctionOct 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "THE CUSTOMER IS COMPLAINING OF EXTENSION SET LEAKAGE OF FLUID AND BLOOD. IN SOME INSTANCES AT BOTH THE MALE LUER CONNECTOR, AND OTHERS AT THE JUNCTION OF THE ULTRASITE CONNECTION TO THE EXTENSION SET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10699117 ↗MalfunctionJun 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THE ADAPTER IS NOT ON ALL THE WAY CAUSING THE TIP TO FALL OFF, AND THE SET ENDS UP LEAKING BLOOD. NO INJURY TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8726279 ↗MalfunctionMar 14, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THEY HAVE BEEN HAVING ISSUES WITH THE PRODUCT LEAKING WHERE THE DISTAL MALE LUER CONNECTS TO THE TUBING. THE LEAKING CAUSES BLOOD TO BACK UP INTO THE TUBING, AND CUSTOMER REPORTS THAT THEY HAD A "BLOODY MESS". NO INJURY REPORTED.
Patient problems: Blood Loss
MAUDE report 8422564 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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