ADDitIV® 352079Recalls & reported problems
B. Braun Medical Inc. · PB603VSL NON-VENT SET · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964181207), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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.
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE ANESTHESIOLOGIST WAS DRAWING UP FLUID AT LOWER PORT AND PULLED AIR INTO UPPER PORT, THE UPPER PORT WAS NOT LIKELY CAPPED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446199 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.