BD Q-Syte 385162Recalls & reported problems
Becton, Dickinson And Company · Tri-Extension Set 15 cm (6 IN) · Class 2
All models of BD Q-Syte (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903851621), received between Aug 7, 2018 and Nov 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Connection Problem1
- Disconnection1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630802 ↗MalfunctionNov 3, 2025Disconnection; Disconnection
ADDITIONAL INFORMATION: ADDITIONALLY, WE HAVE INTERNALLY CONDUCTED A COMPARISON BETWEEN THE OLD AND THE NEW RECEIVED EXTENSION AND IT SEEMS THAT THERE IS A DIFFERENCE IN THE TIP OF THE CONNECTION TUBING, WHICH HAS LED TO THE LOSS OF CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23454762 ↗MalfunctionNov 16, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED BD Q-SYTE TRI-EXTENSION SET HAD LEAKAGE ISSUES.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: ¿THE ANESTHESIA DEPARTMENT HAS DETERMINED THAT WHEN USING THE [TRI-EXTENSION SET] CONNECTED THE 3-WAY-STOPCOK... PROPOFOL LEAKS DROP BY DROP, IT DOES NOT MATTER HOW TIGHT THE CONNECTION IS. IT HAPPENS WITH OTHER FLUIDS AS WELL, BUT BECAUSE PROPOFOL IS KIND OF MILKY IT IS ALSO MORE NOTICEABLE. MOREOVER, THE SAME ISSUE WAS EXPERIENCED TWICE WHEN TWO 3-WAY-STOPCOKS WERE CONNECTED TO EACH OTHER.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12824087 ↗MalfunctionAug 7, 2018Break
IT WAS REPORTED THAT BD Q-SYTE¿ TRI-EXTENSION SET 15 CM (6 IN) 2.25 ML HAD BROKEN VALVES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7757240 ↗
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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
- 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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