BD Q-Syte 385101Recalls & reported problems
Becton, Dickinson And Company · Luer-Lock 15 cm (6 IN) · Class 2
All models of BD Q-Syte (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Q-Syte Luer-Lock extension set is a short IV line used to give fluids and draw blood. The 27 reports mostly describe the set leaking or splashing, plus some complete blockage, cracking, and air getting into the line. No deaths and no injuries were reported, and most reports mention no effect on the patient; one describes a bruise after the set broke and the IV had to be removed. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903851010), received between May 8, 2018 and Nov 10, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (16 reports).
11 other recalls cover devices cleared under the same FDA submission (K013621); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash16
- Air/Gas in Device2
- Break2
- Complete Blockage2
- Gas/Air Leak2
- Defective Component1
- Defective Device1
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient4
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509788 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509753 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22913742 ↗MalfunctionFeb 11, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356097 ↗MalfunctionNov 19, 2023Defective Device; Defective Device
IT WAS REPORTED THAT BD Q-SYTE EXT SET.LUER-LOK 6 IN STD BORE WAS DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; AFTER A CHEST COMPUTED TOMOGRAPHY (CT) EXAMINATION, THE RADIOLOGIST FOUND THAT THE T-JUNCTION OF #385101 WAS DAMAGED, AND CAUSED THE PATIENT'S IV REMOVED. THE PATIENT'S LEFT WRITE WAS FOUND WITH 6X4 CM BRUISE AND SWOLLEN.
Patient problems: Bruise/Contusion
MAUDE report 18167382 ↗MalfunctionOct 11, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE BD Q-SYTE ¿ EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO DRAW BLOOD, AIR LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17917001 ↗MalfunctionOct 11, 2023Gas/Air Leak; Gas/Air Leak
NO NEW INFORMATION RECEIVED UNABLE TO DRAW BLOOD, AIR LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17916920 ↗MalfunctionJul 17, 2023Air/Gas in Device; Air/Gas in Device
NO NEW INFORMATION BUT LATE SAMPLE WAS RECEIVED WHEN BLOOD DRAWN THEN AIR IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339417 ↗MalfunctionJul 17, 2023Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED WHILE USING THE BD Q-SYTE ¿ EXTENSION SET THERE WAS AIR IN THE LINE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: AIR IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339416 ↗MalfunctionDec 6, 2022Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT THE BD Q-SYTE¿ NEEDLE-FREE CONNECTOR LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM MANDARIN CHINESE TO ENGLISH: THERE IS AIR LEAK IN THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15929421 ↗MalfunctionDec 6, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD Q-SYTE¿ NEEDLE-FREE CONNECTOR EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM MANDARIN CHINESE TO ENGLISH: IT WAS REPORTED THAT THE BLOOD CAN'T BE DRAWN, THERE IS AIR LEAK IN THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15921963 ↗MalfunctionAug 12, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING THE BD Q-SYTE EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKAGE FROM HUB. SEEMS BROKEN WHEN CHECK WITH EYES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15218843 ↗MalfunctionJul 13, 2022Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE OF THE BD Q-SYTE¿ NEEDLE-FREE CONNECTOR WITH 15CM (6 IN.) MACRO BORE EXTENSION SET, THE TUBE BROKE AND LEAKAGE OCCURRED FROM THE BROKEN SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE BROKEN, AND LEAKAGE FROM BROKEN SITE. INCIDENT OCCUR : DURING USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008706 ↗MalfunctionMay 6, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED BD Q-SYTE¿ EXTENSION SET HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE BLOOD BETWEEN CATHETER AND HUB, NORMAL AFTER CHANGE A NEW CONNECTOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14311677 ↗MalfunctionApr 20, 2022Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD Q-SYTE¿ EXTENSION SET TUBE WAS BROKEN AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE BROKEN, BLOOD LEAKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14159728 ↗MalfunctionFeb 24, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED WHILE USING BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE THE TUBING DEFORMED DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBE DEFORMATION WHEN PRIMING MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592236 ↗MalfunctionFeb 2, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED BD Q-SYTE EXTENSION SET LEAKED AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE FROM Q-SYTE AND EXTENSION TUBE LUER-PORT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423579 ↗MalfunctionJan 27, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKAGE FROM PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13368850 ↗MalfunctionJan 21, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM MARKED POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13319719 ↗MalfunctionOct 21, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 3 BD Q-SYTE¿ EXTENSION SETS LEAKED FROM THEIR FEMALE PORTS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE FROM FEMALE PORT, AS POINTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12675222 ↗MalfunctionOct 12, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED BD Q-SYTE EXTENSION SET 15 CM WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HUB DEFORMATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12620590 ↗MalfunctionSep 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD Q-SYTE¿ EXTENSION SET TUBING BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE BROKEN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557639 ↗MalfunctionMar 25, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT Q-SYTE EXT SET, LUER-LOK 6 IN STD BORE CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: Q SYTE TUBING THAT CRACKED IN OUR MEDICAL DEPARTMENT. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE LINE BROKE WHEN FLUID WAS FLOWING THROUGH AT 4ML/SEC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11572646 ↗MalfunctionNov 6, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE¿ LUER ACCESS SITE W/ STANDARD BORE EXTENSION SET TUBING WAS DEFECTIVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AT MEDICAL IMAGING A PROBLEM WITH THE BD Q-SYTE EXTENSION SET AT THE LEVEL OF THE CLAMP. THIS REFERENCE CAN BE FOUND IN A NUMBER OF DEPARTMENTS, BUT IT IS ONLY FROM MEDICAL IMAGING THAT I GET A COMPLAINT. BLISTERING OCCURS AT THE POSITION WHERE THE CLAMP HAS BEEN STUCK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9284417 ↗MalfunctionOct 22, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM HAD A VALVE DYSFUNCTION. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VALVE DYSFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9218094 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K013621. One submission often covers many models, so check the product and lot details in each record.
- Z-1317-2015 · Feb 19, 2015 · TerminatedBD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular a
- Z-1074-2010 · Nov 6, 2009 · TerminatedMedical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
- Z-1073-2010 · Nov 6, 2009 · TerminatedMedical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
- Z-1075-2010 · Nov 6, 2009 · TerminatedMedical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
- Z-0752-2010 · Oct 19, 2009 · TerminatedBD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
- Z-0754-2010 · Oct 19, 2009 · TerminatedMPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
- Z-0756-2010 · Oct 19, 2009 · TerminatedMPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
- Z-0751-2010 · Oct 19, 2009 · TerminatedBD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
- Z-0753-2010 · Oct 19, 2009 · TerminatedBD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
- Z-0755-2010 · Oct 19, 2009 · TerminatedMPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
- Z-0750-2010 · Oct 19, 2009 · TerminatedBD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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