BD FACSFlow 342003Recalls & reported problems
Becton, Dickinson And Company · BD FACSFlow™ Sheath Fluid · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903420032), received between Jul 25, 2023 and Nov 21, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD FACSFLOW¿ SHEATH FLUID HAD INCORRECT INFORMATION ON LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR HAVE CHECKED ACTUAL LABEL THEY HAVE IN THE STORAGE FOR BD FACSFLOW PRODUCT 342003 AND THEY HAVE INFORMED ME THAT THEY HAVE PRODUCT WITH INCORRECT GTIN - 59077400243326.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182835 ↗MalfunctionJul 25, 2023Missing Information; Missing Information
IT WAS REPORTED THAT THE BD FACSFLOW¿ SHEATH FLUID WAS MISSING THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO ANY PRODUCT LABEL IS ON BOX
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17392912 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.