Q-Syte 385157Recalls & 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
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903851577), received between Sep 18, 2024 and Feb 2, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (5 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
- Connection Problem5
- Leak/Splash4
- Backflow2
- Material Integrity Problem2
- Break1
- Contamination1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Discomfort1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Leak/Splash; Connection Problem
INCIDENT HAPPENED IN ER DEPARTMENT WHERE AFTER CANNULATION STAFF ATTACHED QSYTE BI EXTENSION CAT NO 385157 ON IV CATHETER 18 G AND WHEN THEY TRIED TO LOCK EXTENSION BY ROTATING SPIN NUT IT GOT FREED DURING TIGHTENING OF IT WHICH RESULTED IN SPILLAGE OF BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235733 ↗MalfunctionDec 16, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
MalfunctionNov 3, 2025Backflow; Backflow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23453130 ↗MalfunctionOct 27, 2025Backflow; Backflow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390508 ↗MalfunctionAug 1, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT BD Q-SYTE BROKEN THREAD WITH DISCONNECTION AND LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE THREADS OF Q-SYTE BI EXTENSION SPIN NUT IS GETTING BROKEN DURING ATTACHING WITH CANULA. CONNECTION GETTING ACCIDENTALLY DISLODGED FROM CANULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686517 ↗MalfunctionJun 25, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET LOOSE COMPONENT AND LEAK THE SPIN NUT KEEPS SPINNING AND DOESN'T FIX TO THE CANNULA, LEADING TO DISCONNECTION AND LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328937 ↗MalfunctionJun 16, 2025Connection Problem; Connection Problem
DESCRIPTION THE LUER LOCK FIXATOR DOESN'T GET FIXED TO THE CANNULA, THE THREAD KEEPS ROTATING AND GETS DISCONNECTED, WHICH LEADS TO LEAKAGE OF BLOOD AND MEDICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210070 ↗MalfunctionJun 9, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET HAD CONNECTION ISSUES INCIDENT HAPPENED IN ER DEPARTMENT WHERE AFTER CANNULATION STAFF ATTACHED QSYTE BI EXTENSION CAT NO 385157 ON IV CATHETER 22G AND WHEN THEY TRIED TO LOCK EXTENSION BY ROTATING SPIN NUT IT GOT FREED DURING TIGHTENING OF IT HENCE CAUSING RISK OF ACCIDENTAL DISLODGEMENT OF CATHETER, THEY HAVE PROVIDED SAMPLES OF 2 BATCHES AND REPLACED QSYTE BI EXTENSION IN PATIENT WITH NEW PIECE OF QSYTE BI EXTENSION WHICH WORKED WITHOUT ANY PROBLEM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22169250 ↗MalfunctionJun 9, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET HAD CONNECTION ISSUES INCIDENT HAPPENED IN ER DEPARTMENT WHERE AFTER CANNULATION STAFF ATTACHED QSYTE BI EXTENSION CAT NO 385157 ON IV CATHETER 22G AND WHEN THEY TRIED TO LOCK EXTENSION BY ROTATING SPIN NUT IT GOT FREED DURING TIGHTENING OF IT HENCE CAUSING RISK OF ACCIDENTAL DISLODGEMENT OF CATHETER, THEY HAVE PROVIDED SAMPLES OF 2 BATCHES AND REPLACED QSYTE BI EXTENSION IN PATIENT WITH NEW PIECE OF QSYTE BI EXTENSION WHICH WORKED WITHOUT ANY PROBLEM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22168792 ↗MalfunctionMay 27, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET COLLAR SPINS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUER LOCK PLUG KEEPS ROTATING, THERE WAS AN EARLIER PIR RAISED, TODAY WE RECEIVED MORE UNITS FROM WARD SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22091755 ↗MalfunctionMay 26, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET HAD A POOR CONNECTION WITH LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LUER LOCK FIXATOR DOESN'T GET FIXED TO THE CANNULA, THE THREAD KEEPS ROTATING AND GETS DISCONNECTED, WHICH LEADS TO LEAKAGE OF BLOOD AND MEDICATIONS. 08-MAY-2025- RECEIVED AN EMAIL RESPONSE. QUANTITY INVOLVED-1. CAN YOU CONFIRM IS THERE ANY PATIENT IMPACTED? - NO. CAN YOU CONFIRM THAT THERE ARE ANY SERIOUS INJURIES THAT OCCUR TO THE PATIENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084658 ↗MalfunctionMay 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028187 ↗MalfunctionMay 7, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE BD Q-SYTE 15CM SMALL BORE BI-EXT SET HAD A LOOSE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LUER LOCK PLUG KEEPS ROTATING AND GETS DISCONNECTED SOON AFTER SECURING. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU CONFIRM IS THERE ANY PATIENT IMPACTED? - YES,THERE WAS A BLOOD SPILLAGE FOR ONE PATIENT, INCIDENT REPORT HAS BEEN RAISED BY THE STAFF NURSE. 2. CAN YOU CONFIRM THAT THERE ARE ANY SERIOUS INJURIES THAT OCCUR TO THE PATIENT? - NO SERIOUS INJURIES. 3. WHAT IS THE CURRENT NURSE STATUS? IS SHE/HE OK? - NURSE IS FINE. 4. QUANTITY INVOLVED - (B)(4) QUANTITIES IN TOTAL OF THE SAME BATCH. 5. DATE OF OCCURRENCE- (B)(6) 2025. THERE WAS A TYPE IN THE DATE OF OCCURRENCE, IT IS (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21981528 ↗MalfunctionJan 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET LEAKED DRUG LEAKAGE FROM Q-SYTE BI EXTENSION IN RADIOLOGY DEPARTMENT. THEY HAVE GIVEN CT CONTRAST AT 5.5ML PER SECOND WITH OVERALL VOLUME OF 80ML THROUGH PRESSURE INJECTOR. THEY HAVE NOTICED DRUG LEAKAGE FROM Q-SYTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21203262 ↗MalfunctionSep 18, 2024Contamination; Contamination
IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET HAD FOREIGN MATTER . DRIED BLOOD LIKE STAIN OBSERVED IN ONE PORT OF Q-SYTE BI EXTENSION (NEAR THE HUB) IN NEW SEALED PACK. OBSERVED BY NURSE IN CHARGE OF ICU OF (B)(6). THE INCIDENT IS ESCALATED TO ICN AND (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20253045 ↗
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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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