Q-Syte 385161Recalls & reported problems
Becton, Dickinson And Company · Bi-Extension Set 15 cm (6 IN) · Class 2
All models of Q-Syte (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00382903851614), received between Nov 15, 2022 and Nov 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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
- Leak/Splash2
- Break1
- Loose or Intermittent Connection1
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 24, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630808 ↗MalfunctionNov 15, 2022Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SET BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE BIOCONNECTOR BREAKS WHEN USED, WITHOUT MISUSE OF IT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15802018 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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