BD Q-Syte 385164Recalls & reported problems
Becton, Dickinson And Company · Tri Extension Set 15 cm (6IN) · Class 2
All models of BD Q-Syte (9)
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 00382903851645), received between Jun 9, 2020 and Oct 7, 2022 — classified as 2 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.
Most reported problems
Device problems
- Break1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2022Break; Break
IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET LUER-LOK COLLAR GOT STUCK IN THE LUMEN AND BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "CUSTOMER INFORMED THAT DURING THE CARE OF A PATIENT, THE LOWER SCREW OF ART. 385164 HAD COME LOOSE. HE THEN INSTRUCTED THAT THE ARTICLES OF THE AFFECTED BATCH (WHICH HE COULD NOT NAME) BE PUT ASIDE AND NOT USED FOR THE TIME BEING.. ACCORDING TO THE CUSTOMER THE PRODUCT DOES NOT HAVE A ¿SCREW (SCHRAUBE)¿ WE ASKED FOR CLARIFICATION, AND THE CUSTOMER DESCRIBED THE FOLLOWING: ¿HUB BROKE AND GOT STUCK IN THE LUMEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15561023 ↗MalfunctionJun 9, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT TRI-EXT SET 15CM SMALL BORE SPIN NUT WAS MISSING LOCKING CLAMP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 LUMEN IS MISSING A WHITE LOCKING CLAMP.
Patient problems: No Patient Involvement
MAUDE report 10135864 ↗
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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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