BD Q-Syte 385102Recalls & reported problems
Becton, Dickinson And Company · Extension Set Luer-Lock, 15 cm (6 IN) · Class 2
All models of BD Q-Syte (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Q-Syte extension set is an intravenous tubing connector used to link lines during infusions. Of its 278 reports, 277 are malfunction reports, mostly describing fluid leaks and splashes, and some describing blockages or broken parts. One report is an injury report, and there were no deaths. No recalls name 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
- 269
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 00382903851027), received between Jan 29, 2018 and Sep 30, 2026 — classified as 1 injury, 268 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (189 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash189
- Defective Component21
- Fluid/Blood Leak19
- Device Contamination with Chemical or Other Material18
- Break17
- Complete Blockage17
- Crack6
- Loose or Intermittent Connection4
Patient problems
- No Clinical Signs, Symptoms or Conditions178
- No Known Impact Or Consequence To Patient56
- No Consequences Or Impact To Patient38
- Insufficient Information3
- Alteration In Body Temperature1
- Anxiety1
- Blood Loss1
- Discomfort1
Recent adverse event reports
The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949383 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921297 ↗MalfunctionJun 10, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25458979 ↗MalfunctionMay 27, 2026Nonstandard Device; Obstruction of Flow
ON (B)(6) 2026, A PEDIATRIC PATIENT WAS RECEIVING INTRAVENOUS NUTRITION TO PROVIDE BASIC LIFE SUPPORT AND PREVENT MALNUTRITION. AN IV SET WAS CONNECTED TO ADMINISTER THE INTRAVENOUS NUTRITION, BUT IT WAS DISCOVERED THAT THE FLUID WAS NOT FLOWING PROPERLY. UPON INSPECTION, IT WAS FOUND THAT THE RUBBER STOPPER ON THE CONNECTOR WAS NOT SPRINGING BACK, PREVENTING THE FLUID FROM FLOWING PROPERLY. THE CONNECTOR WAS REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303198 ↗MalfunctionMay 20, 2026Separation Problem
DURING USE, WE DISCOVERED THAT THE EXTENSION TUBING AND THE END CAP HAD BECOME DETACHED; THERE IS ONE DEFECTIVE UNIT. THE DEFECTIVE PRODUCT HAS BEEN RETURNED, AND PHOTOGRAPHS ARE AVAILABLE. WE REQUIRE A CLAIM SETTLEMENT, A RESPONSE TO OUR COMPLAINT, AND A RECEIPT OF COMPLAINT ACKNOWLEDGMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231355 ↗MalfunctionMay 11, 2026Leak/Splash
A FEMALE INFANT WAS ADMITTED TO OUR DEPARTMENT WITH NEONATAL SEPSIS. ON (B)(6), 2026, WHILE A NURSE WAS ADMINISTERING INTRAVENOUS THERAPY USING A NEEDLELESS INJECTION CAP TO CONNECT THE INFUSION SYSTEM, SHE NOTICED SIGNIFICANT RESISTANCE DURING FLUSHING OF THE MEDIUM-LENGTH CATHETER. UPON INSPECTION, FLUID LEAKAGE WAS DETECTED FROM THE NEEDLELESS INJECTION CAP. IMMEDIATELY FOLLOWING THE INCIDENT, THE INJECTION CAP WAS REPLACED, AND AFTER CONFIRMING THAT EVERYTHING WAS IN ORDER, INTRAVENOUS THERAPY WAS RESUMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137095 ↗MalfunctionMay 8, 2026Leak/Splash
DURING USE, THERE WAS LEAKAGE FROM THE CONNECTOR (1 DEFECTIVE UNIT) AND EMPTY PACKAGING(B)(4) DEFECTIVE UNITS). THE DEFECTIVE PRODUCTS WERE RETURNED, AND A RETURNED PHOTOGRAPH IS AVAILABLE. WE REQUIRE A CLAIM SETTLEMENT, A RESPONSE TO THE COMPLAINT, AND A RECEIPT OF THE COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124124 ↗MalfunctionMay 4, 2026Leak/Splash; Nonstandard Device
(B)(6) 2026 THE NURSE IN CHARGE OF THE NOON TO THE CENTRAL VENOUS CATHETER REPLACEMENT OF UXI FOUND A SEPTUM NEEDLELESS SEALED INFUSION CONNECTOR POSITIVE PRESSURE CONNECTOR CONNECTION LEAKAGE, TWO PEOPLE TO CONFIRM THE OBVIOUS LEAKAGE OF FLUID, THE QUALITY OF THE QUALITY IS NOT QUALIFIED, AND THEN RE-REPLACE THE CONNECTOR AFTER THE NORMAL INFUSION. NURSING STAFF UNPACKED THE OUTER PACKAGING AND FOUND THAT THE CANNULA CONNECTOR WAS DISLODGED AND COULD NOT BE USED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069267 ↗MalfunctionApr 17, 2026Leak/Splash
ON (B)(6), WHILE ADMINISTERING AN IV INFUSION TO A PATIENT USING A SEALED CONNECTOR, I NOTICED FLUID LEAKING FROM THE CONNECTION POINT, SO I REPLACED IT WITH A NEW SEALED CONNECTOR AND COMPLETED THE PROCEDURE. HELLO, I HAVE CONTACTED THE CLINICAL DEPARTMENT AT THE HOSPITAL. THE DEPARTMENT HAS DISPOSED OF THE PROBLEMATIC CONNECTOR AND DID NOT RETAIN ANY RELATED PHOTOGRAPHS. AFTER INQUIRING ABOUT THE CIRCUMSTANCES OF THE INCIDENT, THE DEPARTMENT RECEIVED RELEVANT TRAINING AND CLARIFICATION TO PREVENT SUCH ISSUES FROM OCCURRING AGAIN. WE ALSO HOPE TO URGE THE MANUFACTURER TO IMPROVE ITS PRODUCTION AND QUALITY CONTROL PROCESSES TO PREVENT COMPLAINTS AND ADVERSE EVENT REPORTS CAUSED BY PRODUCT QUALITY ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915763 ↗MalfunctionApr 15, 2026Leak/Splash
IF LEAKAGE OCCURS DURING USE, A GREEN CLAIM IS REQUIRED; THE PHYSICAL DEVICE HAS NOT BEEN RETURNED; VIDEO EVIDENCE IS AVAILABLE; NO RESPONSE TO THE COMPLAINT IS REQUIRED; NO ACKNOWLEDGMENT OF RECEIPT FOR THE COMPLAINT IS REQUIRED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24887943 ↗MalfunctionMar 17, 2026Material Invagination; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617975 ↗MalfunctionMar 16, 2026Crack
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607241 ↗MalfunctionMar 16, 2026Break
THE PATIENT RECEIVED AN IV CATHETER ON THE 9TH. ON THE MORNING OF THE 10TH, DURING THE PROCESS OF CONNECTING THE IV FLUID LINE, IT WAS DISCOVERED THAT THE NEEDLE-FREE CONNECTOR HAD BROKEN OFF. THE BREAK OCCURRED NOT AT THE LOCKING MECHANISM, AND THE PATIENT-SIDE CONNECTION LACKED ANY LOCKING FEATURE. THE CATHETER WAS INSERTED INTO THE GREAT SAPHENOUS VEIN, WHICH HAS ABUNDANT BLOOD FLOW. FORTUNATELY, A SMALL CLOT AT THE NEEDLE SITE MAY HAVE BLOCKED THE NEEDLE, HALTING BLOOD FLOW. THE CHILD HAD BEEN WITH THE BROKEN NEEDLE FOR AN UNKNOWN PERIOD. THANKFULLY, NO BLEEDING OCCURRED; OTHERWISE, THE CONSEQUENCES WOULD HAVE BEEN UNIMAGINABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606286 ↗MalfunctionMar 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606285 ↗MalfunctionMar 13, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594478 ↗MalfunctionJan 30, 2026Crack; Leak/Splash
ON (B)(6) 2026, PRIOR TO ADMINISTERING INTRAVENOUS FLUIDS TO THE PEDIATRIC PATIENT, THE CATHETER LINE WAS INSPECTED. DURING FLUSHING, FLUID LEAKAGE WAS OBSERVED. EXAMINATION REVEALED A CRACK AT THE ORIGINAL CLAMP SITE OF THE NEEDLE-FREE CLOSED-SYSTEM INFUSION CONNECTOR EXTENSION TUBE. THE CLAMP WAS IMMEDIATELY SECURED, AND A NEW NEEDLE-FREE CLOSED-SYSTEM INFUSION CONNECTOR WAS INSTALLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223359 ↗MalfunctionJan 27, 2026Break; Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE COMPONENT DAMAGE AND LEAKED THE FRONT END OF A CLOSED-SYSTEM IV CONNECTOR RUPTURED, CAUSING MEDICATION LEAKAGE. MEDICAL STAFF PROMPTLY REPLACED THE CONNECTOR UPON DISCOVERY, PREVENTING ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189506 ↗MalfunctionJan 23, 2026Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE LEAKED ON (B)(6) 2025, AT APPROXIMATELY 4:00 PM, WHILE ATTEMPTING TO INSERT AN INTRAVENOUS CATHETER INTO A PEDIATRIC PATIENT, THE SYRINGE FAILED TO CONNECT TO THE NEEDLE-FREE ADAPTER. THE SYRINGE WOULD POP OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163476 ↗MalfunctionJan 21, 2026Leak/Splash; Manufacturing, Packaging or Shipping Problem
WHEN IN USE, LEAKAGE IS FOUND AT THE CONNECTOR JOINTS,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130325 ↗MalfunctionJan 8, 2026Break; Leak/Splash
IT WAS REPORTED THAT BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE COMPONENT DAMAGE AND LEAKED THE PATIENT, DIAGNOSED WITH PREMATURE INFANT DISEASE, WAS ADMINISTERED A NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH A DIAPHRAGM VALVE MANUFACTURED BY BECTON DICKINSON MEDICAL DEVICES (SHANGHAI) CO., LTD. ON (B)(6) 2025. THE CONNECTOR WAS REPLACED ON (B)(6). ON THE MORNING OF (B)(6), LEAKAGE OCCURRED AT THE CONNECTOR DURING ROUTINE SALINE FLUSHING. UPON CLOSE INSPECTION, A RUPTURE IN THE DIAPHRAGM VALVE WAS IDENTIFIED. UPON LEARNING OF THIS, THE NURSE TOOK MEASURES INCLUDING REPLACING THE SEPTUM-TYPE NEEDLE-FREE CLOSED INFUSION CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005752 ↗MalfunctionJan 7, 2026Break; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23997461 ↗MalfunctionJan 7, 2026Connection Problem
IT WAS REPORTED THAT BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE HAD CONNECTION ISSUES THE PATIENT, DIAGNOSED WITH NRDS AND PREMATURE INFANT DISEASE, WAS ADMINISTERED A NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH A DIAPHRAGM VALVE MANUFACTURED BY BD MEDICAL DEVICES (SHANGHAI) CO., LTD. ON (B)(6) 2025. AT 9:00 AM THAT DAY, DURING ROUTINE LONG-TERM TREATMENT, THE TEMPORARY FLUID CONNECTOR WAS REMOVED, REVEALING A MALFUNCTION WHERE ONE SIDE OF THE DIAPHRAGM VALVE WAS INDENTED AND FAILED TO REBOUND. UPON LEARNING OF THIS, THE NURSE TOOK CORRECTIVE MEASURES, INCLUDING REPLACING THE DIAPHRAGM VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23997395 ↗MalfunctionDec 11, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23779758 ↗MalfunctionNov 11, 2025Failure to Disconnect; Failure to Disconnect
ON (B)(6) 2025, WHEN THE NURSE ATTEMPTED TO REUSE THE CONSUMABLE, THE INFUSION CONNECTOR ADHERED TO THE INFUSION SET AFTER CONNECTION AND COULD NOT BE SEPARATED. AFTER FORCIBLE SEPARATION, THE SEPTUM REMAINED STUCK TO THE INFUSION SET END AND COULD NOT BE REMOVED. THIS PREVENTED NORMAL INFUSION THERAPY, RESULTING IN WASTED CONSUMABLES AND SEVERELY DISRUPTING THE INFUSION PROCESS, THEREBY DELAYING PATIENT TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523722 ↗MalfunctionOct 30, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425389 ↗
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-1075-2010 · Nov 6, 2009 · TerminatedMedical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
- 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-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-0755-2010 · Oct 19, 2009 · TerminatedMPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
- 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-0750-2010 · Oct 19, 2009 · TerminatedBD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, 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-0753-2010 · Oct 19, 2009 · TerminatedBD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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