IV Administration Set 490368Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET W/15 DROPS/ML,120 IN. · Class 2
All models of IV Administration Set (153)
Data updated Oct 16, 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 04046964669927), received between Nov 18, 2016 and Nov 18, 2016 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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
- Device Operates Differently Than Expected3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: REPORTS AN IV WAS STARTED WITH 500 ML 0.9% SODIUM CHLORIDE ATTACHED TO A PATIENT. THE ROLLER CLAMP WAS ADJUSTED TO A SLOW DRIP FOR KVO RATE. THIRTY MINUTES LATER, THE BAG WAS EMPTY. THE NURSE TRIED ADJUSTING THE ROLLER CLAMP ON ANOTHER SET AND NOTED IT HAD TO BE ROLLED ALL THE WAY TO ALMOST OFF TO ALLOW FOR A VERY SLOW DRIP RATE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6112798 ↗MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT # 2: REPORTS THAT AFTER PRIMING THE IV TUBING THE ROLLER CLAMP IS CLOSED. HOWEVER, THE TUBING CONTINUED TO FLOW FROM THE TRIPLE STOPCOCK AREA OF THE SET TO THE LUER LOCK ENDING. THEREFORE, THE SET WAS NOT COMPLETELY PRIMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6112792 ↗MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS THAT AFTER PRIMING THE IV TUBING THE ROLLER CLAMP IS CLOSED. HOWEVER, THE TUBING CONTINUED TO FLOW FROM THE TRIPLE STOPCOCK AREA OF THE SET TO THE LUER LOCK ENDING. THEREFORE, THE SET WAS NOT COMPLETELY PRIMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6112791 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- IV Administration Set 490432B. Braun Medical Inc. · Stopcock, i.V. Set1 recall3 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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