ULTRASITE® US1921Recalls & reported problems
B. Braun Medical Inc. · Secondary IV Set with ULTRASITE® Injection Site · Class 2
All models of ULTRASITE (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04046964187971), received between Nov 16, 2018 and Apr 13, 2022 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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.
Most reported problems
Device problems
- Fluid/Blood Leak12
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient2
- Chemical Exposure1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PATIENT WAS RECEIVING CHEMO AND THE TUBING BROKE AT THE DISTAL JUNCTION OF THE US1921 NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14102032 ↗MalfunctionJan 19, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CHEMO LEAK BELOW ULTRASITE VALVE ON TUBING AT JUNCTION. LEAKAGE NOTICED AFTER 20 ML OF CHEMO INFUSED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289465 ↗MalfunctionJan 19, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CHEMO LEAK BELOW ULTRASITE VALVE ON TUBING AT JUNCTION. LEAKAGE NOTICED AFTER 20 ML OF CHEMO INFUSED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289464 ↗MalfunctionMay 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING INFUSION OF CARBOPLATIN, IT WAS NOTICED THAT THERE WAS A LEAK IN THE TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11786920 ↗MalfunctionMay 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT AT THE END OF CAELYX INFUSION, RED DROPS WERE SEEN ON THE FLOOR BEDSIDE PATIENT'S CHAIR AND RED LIQUID ON THE SIDE OF IV PUMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11786887 ↗MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT CHEMO LEAKED BELOW THE Y-SITE ON PRODUCT CODE US1921. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11587684 ↗MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT CHEMO LEAKED BELOW THE Y-SITE ON PRODUCT CODE US1921. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11587681 ↗MalfunctionJul 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF CAMPTOSAR, THE TUBING LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10265015 ↗MalfunctionMay 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF DOXORUBICIN, THE TUBING BROKE AT THE Y-SITE CONNECTION AND LEAKED. NO INJURY REPORTED.
Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient
MAUDE report 10097298 ↗MalfunctionAug 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE ULTRASITE LEAKED AND CHEMO DRIPPED ON THE FLOOR. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8882732 ↗MalfunctionJun 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT AT THE END OF THE INFUSION DROPS OF EPRATUZUMAB WERE FOUND AT THE TUBING JUNCTION BELOW THE ULTRASITE VALVE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8704759 ↗MalfunctionJun 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SECONDARY TUBING WAS LEAKING AT THE Y-SITE. PATIENT WAS RECEIVING DOXORUBICIN IV, DURING THE RINSE OF THE CHEMO, IT WAS NOTICED THAT CHEMO WAS LEAKING FROM THE Y ULTRASITE ON THE SECONDARY TUBING. APPROXIMATELY 10 ML WAS NOTICED ON THE IV POSE AND THE TUBING - AS WELL AS DROPS ON THE FLOOR. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8704758 ↗MalfunctionJun 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING A CHEMOTHERAPY INFUSION, THE PRODUCT LEAKED CAUSING CHEMO TO DRIP ON THE FLOOR. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8690982 ↗MalfunctionNov 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORT BY THE USER FACILITY: THE NURSE OBSERVED CHEMOTHERAPY ON THE SURFACE OF THE SECONDARY TUBING. NO INJURIES WERE REPORTED. LIMITED INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8077762 ↗MalfunctionNov 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORT BY THE USER FACILITY: THE NURSE OBSERVED CHEMOTHERAPY ON THE SURFACE OF THE SECONDARY TUBING. NO INJURIES WERE REPORTED. LIMITED INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8077749 ↗
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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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