Extension Set 490238Recalls & reported problems
B. Braun Medical Inc. · EXT SET W/ 6 B/C VALVES, 17 IN · Class 2
All models of Extension Set (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964716409), received between Aug 14, 2018 and Aug 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0636-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT, THE PATIENT HAS HAD VALVE REPLACEMENT IN THE PAST. IN NOVEMBER THE PATIENT REFUSED VALVE SURGERY. THE PATIENT CONTINUED TO HAVE SWELLING AND RESPIRATORY DISTRESS. THE PATIENT THEN AGREED TO HAVE VALVE SURGERY. THE PATIENT CAME TO THE HOSPITAL AS TRANSFER DUE TO INCREASED SWELLING IN LEGS. THE PATIENT ARRIVED FROM THE OR, WITH CHEST OPEN, SEALED WITH IOBAN AND ESMARK, ON A MULTI-PRESSORS. PATIENT HAD AVR AND ASCENDING AORTIC ROOT REPAIR. THE PATIENT WAS IN HOSPITAL A FEW DAYS BEFORE SURGERY. UNEVENTFUL OR. PATIENT MAINTAINED BLOOD PRESSURE IN THE OR DURING LAST HOUR AND A HALF. THE PATIENT WAS THEN TRANSFERRED TO BED FROM OR TABLE, THEN BROUGHT OUT TO OPEN HEART RECOVERY. WITHIN A FEW MINUTES OF ARRIVING TO THE ICU NURSE NOTICED 250 CC OF BLOOD WAS DUMPED INTO CHEST TUBE. TEAM THEN CONCERNED WITH BLEEDING, GAVE BOLUS OF NORMAL SALINE, ALBUMIN AND EPI; HOWEVER, BLOOD PRESSURE CONTINUED TO DROP. THE PATIENT WAS PREPPED TO HAVE OPEN CHEST AT BEDSIDE AND NOTICED THAT THE SHEETS WERE WET AND DRIPPING OFF SIDE OF BED. CHRISTMAS TREE LEAKING AT ONE CONNECTION POINT, THE CENTER OF CHRISTMAS TREE WAS LEAKING. INTERNAL CARDIAC MESSAGE PE
Patient problems: Cardiac Arrest
MAUDE report 7781757 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- 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 · each recall links to the FDA recall notice
- 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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