ULTRASITE® 473448Recalls & reported problems
B. Braun Medical Inc. · Small Bore Extension Set with Bonded ULTRASITE® Valve · Class 2
All models of ULTRASITE (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964185366), received between May 22, 2019 and Oct 9, 2023 — classified as 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
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE PATIENT HAS EXPERIENCED BLOOD LEAKING FROM THE CATHETER BECAUSE THE NURSING TEAM DID NOT KNOW HOW TO USE SPIN LOCK PROPERLY. THEY ARE NOW EDUCATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17895141 ↗MalfunctionOct 9, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE PATIENT HAS EXPERIENCED BLOOD LEAKING FROM THE CATHETER BECAUSE THE NURSING TEAM DID NOT KNOW HOW TO USE SPIN LOCK PROPERLY. THEY ARE NOW EDUCATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17895130 ↗MalfunctionMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "A PATIENT WAS HAVING A PROCEDURE DONE IN X-RAY AND WHILE THE NURSE WAS INJECTING INTO PRODUCT 473448, IT BLEW APART. WHEN THE EXTENSION SET CAME APART, THE PATIENT DID BLEED ONTO THE STRETCHER. A CT CHEST W/ IV CONTRAST (OMNIPAQUE 300) WAS PERFORMED. A MEDRAD PRESSURE INJECTOR WAS USED AT A RATE OF 3 ML/SEC. PATIENT'S ARM WAS FULLY EXTENDED DURING INFUSION WITH NO KINKS IN THE TUBING. AFTER THE INCIDENT, THE EXTENSION SET WAS REPLACED WITH NEW EXTENSION SET AND THE EXAM WAS DONE WITH NO PROBLEMS."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8634007 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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