IV Administration Set 490432Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET W/ 15 DROPS/ML, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964832826), received between Mar 8, 2022 and Dec 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
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-0685-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Leak/Splash2
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Material Split, Cut or Torn
WHEN THE PACKAGE WAS OPENED, SET WAS DISCOVERED TO BE IN 2 PIECES LIKE IT WAS CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778784 ↗MalfunctionApr 11, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: "WE HAD A PATIENT WITH IV SET 490432 THAT BECAME DISCONNECTED WHEN BEING TRANSFERRED TODAY. THERE WAS LEAKING OF IV FLUIDS AND BLOOD. IT APPEARED TO BE ABOUT 50-100CC OF BLOOD THAT LEAKED. I TIGHTENED THE CONNECTIONS AND THE LEAKING STOPPED. I'M NOT SURE IF THE CONNECTIONS WERE TIGHTENED BEFORE THE CASE AS I TOOK OVER FOR ANOTHER CLINICIAN." NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14072827 ↗MalfunctionMar 8, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE IV SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13700688 ↗
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.