ULTRASITE® 473443Recalls & reported problems
B. Braun Medical Inc. · Standard Bore T-port extension Set with ULTRASITE® Valve · Class 2
All models of ULTRASITE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964185267), received between Aug 6, 2018 and Aug 6, 2018 — classified as 4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- Blood Loss4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: THERE HAVE BEEN FOUR INCIDENTS OF BLOOD LEAKAGE AT THE T-PORT AREA OF THE EXTENSION SET, WHICH INVOLVED PATIENTS LOSING BLOOD. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 7754183 ↗MalfunctionAug 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: THERE HAVE BEEN FOUR INCIDENTS OF BLOOD LEAKAGE AT THE T-PORT AREA OF THE EXTENSION SET, WHICH INVOLVED PATIENTS LOSING BLOOD. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 7754182 ↗MalfunctionAug 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: THERE HAVE BEEN FOUR INCIDENTS OF BLOOD LEAKAGE AT THE T-PORT AREA OF THE EXTENSION SET, WHICH INVOLVED PATIENTS LOSING BLOOD. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 7754133 ↗MalfunctionAug 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: THERE HAVE BEEN FOUR INCIDENTS OF BLOOD LEAKAGE AT THE T-PORT AREA OF THE EXTENSION SET, WHICH INVOLVED PATIENTS LOSING BLOOD. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 7754132 ↗
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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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