ULTRASITE® 473992Recalls & reported problems
B. Braun Medical Inc. · 0.2 Micron Filtered Extension Set with ULTRASITE® Injection Site · Class 2
All models of ULTRASITE (12)
Data updated Oct 18, 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 04046964185465), received between Sep 15, 2017 and Sep 29, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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 18, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem2
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
- 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.
MalfunctionSep 29, 2017Infusion or Flow Problem; Infusion or Flow Problem
PER MEDWATCH NUMBER: MW5071699. EVENT 1: EVENT DESCRIPTION: FILTER STARTED TO FILL WITH AIR WITHOUT ADDING AIR TO THE LINE. TWO FILTERS WITH THE SAME LOT NUMBER DID THIS. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6903331 ↗MalfunctionSep 29, 2017Infusion or Flow Problem; Infusion or Flow Problem
PER MEDWATCH NUMBER: MW5071699. EVENT 2: EVENT DESCRIPTION: FILTER STARTED TO FILL WITH AIR WITHOUT ADDING AIR TO THE LINE. TWO FILTERS WITH THE SAME LOT NUMBER DID THIS. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6903322 ↗MalfunctionSep 15, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THERE WAS A CRACK ON THE FILTER OF THE EXTENSION SET CAUSING CHEMO TO LEAK DURING USE. CHEMOTHERAPY BEING INFUSED WAS ETOPOSIDE, DOXORUBICIN, AND VINCRISTINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6871093 ↗
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
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- 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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