IV Administration Set 490329Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET, 81 IN W/ 32 IN EXT SET · Class 2
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 04046964541100), received between Mar 21, 2017 and Mar 21, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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-0653-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 2: STOPCOCK ASPECT IS COMING LOOSE, AND LEAKING BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6421624 ↗MalfunctionMar 21, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 1: STOPCOCK ASPECT IS COMING LOOSE, AND LEAKING BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6421621 ↗
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
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.