IV Administration Set 490552Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET 15D, 5 CARESITE INJ, 150in. · Class 2
All models of IV Administration Set (153)
Data updated Oct 16, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955275342), received between Oct 7, 2024 and Oct 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
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-0670-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Free or Unrestricted Flow2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Free or Unrestricted Flow; Free or Unrestricted Flow
AS REPORTED, THE CUSTOMER STATES THE ROLLING BALL CLAMP IS NOT WORKING PROPERLY. EVEN WHEN YOU ROLL IT ALL THE WAY DOWN IT STILL ALLOWS FLUID TO PASS THROUGH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427399 ↗MalfunctionOct 7, 2024Free or Unrestricted Flow; Free or Unrestricted Flow
AS REPORTED BY USER FACILITY, THE ROLLING CLAMP DOES NOT WORK PROPERLY. WITH IT ROLLED ALL THE WAY DOWN IT DOES NOT STOP THE FLOW FROM THE IV BAG OF FLUIDS. SO PATIENTS IN TURN ARE GETTING A BOLUS OF FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385686 ↗
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 · each recall links to the FDA recall notice
- 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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