Extension Set 490443Recalls & reported problems
B. Braun Medical Inc. · EXT SET W/3 ULTRAPORT ZERO · Class 2
All models of Extension Set (41)
Data updated Oct 16, 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 04046964834097), received between Oct 25, 2017 and Jul 19, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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 16, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2018Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE STOPCOCK MANIFOLD IS NOT BONDED TO THE SET AND AIR GETS IN THE LINE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7704633 ↗MalfunctionOct 25, 2017Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS THAT THE EXTENSION SETS ARE CONTINUALLY ALLOWING AIR IN CAUSING BUBBLES AT THE END OF THE CONNECTION OF TUBING AND MANIFOLD. THIS WAS NOTICED WHEN ATTEMPTING TO INJECT. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6976428 ↗MalfunctionOct 25, 2017Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS THAT THE EXTENSION SETS ARE CONTINUALLY ALLOWING AIR IN CAUSING BUBBLES AT THE END OF THE CONNECTION OF TUBING AND MANIFOLD. THIS WAS NOTICED WHEN ATTEMPTING TO INJECT. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6976424 ↗MalfunctionOct 25, 2017Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS THAT THE EXTENSION SETS ARE CONTINUALLY ALLOWING AIR IN CAUSING BUBBLES AT THE END OF THE CONNECTION OF TUBING AND MANIFOLD. THIS WAS NOTICED WHEN ATTEMPTING TO INJECT. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6976403 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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