ADDitIV® V1447Recalls & reported problems
B. Braun Medical Inc. · ADDITIVE SET W/ 3 INJ SITES -DR* · Class 2
All models of ADDitIV (7)
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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964188411), received between Apr 30, 2024 and Apr 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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-0603-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash1
- Material Puncture/Hole1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): BACKFLOW OF THE PTS BLOOD WAS IN THE IV LINE. UPON OBSERVATION THERE WAS A HOLE IN THE LINE BETWEEN THE PORTS WHICH CAUSED BLOOD TO LEAK ON THE FLOOR AND SPRAY ON OUR TREADMILL CASE SYSTEM. HOW WAS IT DETECTED? A HOLE IN THE IV TUBING CAUSING BLOOD TO LEAK. DESCRIBE REPORTED PROBLEM/EVENT IN DETAIL: (USE ANOTHER SHEET IF NECESSARY) TUBING WAS ATTACHED TO PATIENT AND FLUSHED. HUB WAS CONNECTED FOR PERSANTINE INFUSION. TECH THEN STEPPED AWAY FROM PATIENT TO REVIEW PAPERWORK WITH PHYSICIAN. UPON RETURN TO THE ROOM, THERE WAS SPILL OF BLOOD ALONG THE PROCEDURE ROOM FLOOR AND EQUIPMENT. TEST WAS COMPLETED AND THE PATIENT WAS REMOVED FROM THE AREA AND ROOM WAS WIPED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19212962 ↗
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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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