IV Administration Set 490340Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET, QUAD MANIFOLD,120 IN. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964590481), received between Nov 17, 2016 and Nov 17, 2016 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 reports).
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0689-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected4
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.
MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 5: REPORTS THAT THE SET FALLING APART AT NON-BONDED PORTION DURING USE, EVEN AFTER TIGHTENING, AND ROLLER CLAMP LOOSENING UP AFTER IT WAS SET TO ADMINISTER AT A "KVO" RATE PREOPERATIVELY, THEREFORE HAVING MORE FLUID ADMINISTER PREOPERATIVELY THAN PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109266 ↗MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 4: REPORTS THAT THE SET FALLING APART AT NON-BONDED PORTION DURING USE, EVEN AFTER TIGHTENING, AND ROLLER CLAMP LOOSENING UP AFTER IT WAS SET TO ADMINISTER AT A "KVO" RATE PREOPERATIVELY, THEREFORE HAVING MORE FLUID ADMINISTER PREOPERATIVELY THAN PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109264 ↗MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 3. REPORTS THAT THE SET FALLING APART AT NON-BONDED PORTION DURING USE, EVEN AFTER TIGHTENING, AND ROLLER CLAMP LOOSENING UP AFTER IT WAS SET TO ADMINISTER AT A "KVO" RATE PREOPERATIVELY, THEREFORE HAVING MORE FLUID ADMINISTER PREOPERATIVELY THAN PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109246 ↗MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 2. REPORTS THAT THE SET FALLING APART AT NON-BONDED PORTION DURING USE, EVEN AFTER TIGHTENING, AND ROLLER CLAMP LOOSENING UP AFTER IT WAS SET TO ADMINISTER AT A "KVO" RATE PREOPERATIVELY, THEREFORE HAVING MORE FLUID ADMINISTER PREOPERATIVELY THAN PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109244 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.