BD Q-Syte 385100Recalls & reported problems
Becton, Dickinson And Company · Q-Syte · 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 closed luer access device is a connector set used to give fluids and medicines into a vein. The 986 reports often describe leaks at the connector, complete blockages, and parts breaking. Reports include 1 death and 24 injuries. 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
- 971
- Deaths reported
- 1
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 971 adverse event reports that list this exact device (DI 00382903851003), received between Oct 23, 2017 and Sep 29, 2026 — classified as 1 death, 24 injuries, 946 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (533 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/Splash533
- Fluid/Blood Leak85
- Complete Blockage78
- Break71
- Defective Component68
- Device Contamination with Chemical or Other Material50
- Crack45
- Material Separation14
Patient problems
- No Clinical Signs, Symptoms or Conditions590
- No Known Impact Or Consequence To Patient218
- No Consequences Or Impact To Patient99
- Insufficient Information34
- No Patient Involvement18
- No Information9
- Low Blood Pressure/ Hypotension4
- Unspecified Infection4
Recent adverse event reports
The 25 most recent of 971 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936985 ↗MalfunctionSep 18, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831248 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: Insufficient Information
MAUDE report 50787123 ↗MalfunctionSep 1, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548884 ↗InjuryAug 3, 2026Leak/Splash
It was reported that BD Q-SYTE CLOSED LUER ACCESS DEVICE component was cracked and leaked.I am writing to inform you of an incident that occurred on (b)(6) 2026.Incident details: It was reported that Change of intravenous cyclosporine syringe at 15:00. At around 20:30, the solution was leaking from the pumps onto the floor and the cyclosporine syringe was filled with saline. The Q-syte was completely cracked. The child received little or no cyclosporine.Immediate action: Line changed. Ciclosporin levels monitored over the following days and doses increased.Apparent immediate consequences: For the patient: Underdosing of ciclosporin.
Patient problems: Insufficient Information
MAUDE report 50118019 ↗MalfunctionJul 2, 2026Infusion or Flow Problem
IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE BACK FLOWS. AFTER A NURSE INSERTS AN INTRAVENOUS CATHETER INTO A PEDIATRIC PATIENT, BLOOD FLOWS BACK TO THE SURFACE OF THE DIVIDER AND INTO THE GROOVES, FORMING DRIED BLOOD STAINS THAT ARE DIFFICULT TO WIPE AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696490 ↗MalfunctionJul 1, 2026Complete Blockage; Nonstandard Device
IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE SEPTUM DID NOT REBOUND AND FLUID DID NOT INFUSE. (B)(6) 2026, 15:15, READY FOR THE PATIENT INFUSION TREATMENT, CONNECTED TO THE SEPTUM NEEDLELESS CLOSED INFUSION CAP, FIRST WITH A SYRINGE TO FLUSH THE TUBING, AND THEN CONNECTED TO THE INFUSION SET, FOUND THAT THE INFUSION DOES NOT DRIP, REMOVE THE INFUSION SET FOUND THAT THE INTERNAL PARTS OF THE SEPTUM NEEDLELESS CLOSED INJECTION CAP DID NOT REBOUND OUT, RESULTING IN THE FLUID DOES NOT DRIP, THAT IS, TO REPLACE THE NEW SEPTUM NEEDLELESS CLOSED INFUSION CAP TO THE PATIENT FOR THE INFUSION TREATMENT, REPLACEMENT AFTER REPLACEMENT, THE INFUSION WAS SMOOTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679114 ↗MalfunctionJun 30, 2026Material Integrity Problem
IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE COMPONENT WAS DAMAGED AND OCCLUSION OCCURRED. ON (B)(6) 2026, AT 15:15, THE NURSE WAS PREPARING TO GIVE A PATIENT AN INFUSION, FLUSHING THE TUBING FOR THE PATIENT WITH A SYRINGE AND THEN CONNECTING THE INFUSION SET, AND FOUND THAT THE INFUSION WAS NOT DRIPPING, AND REMOVED THE INFUSION SET IN ORDER TO FLUSH THE TUBING AGAIN, AND FOUND THAT THE INTERNAL PARTS OF THE SEPTUM NEEDLELESS INJECTION CAP HAD NOT REBOUNDED, RESULTING IN THE FLUID NOT DRIPPING. THE PATIENT WAS GIVEN A NEW SEPTUM NEEDLELESS INJECTION CAP TO USE, AND THE INFUSION WAS SMOOTH AFTER THE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667623 ↗MalfunctionJun 30, 2026Leak/Splash; Material Integrity Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE WAS DEFECTIVE AND LEAKED. IT WAS REPORTED THAT LEAKAGE FOUND DURING DRUG ADMINISTRATION AT PICC; SUSPECTED Q SITE DAMAGE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666685 ↗MalfunctionJun 8, 2026Break; Leak/Splash
PRIOR TO USING A SEPTUM NEEDLELESS INJECTION CAP ON (B)(6) 2026, A HEPATOBILIARY SURGERY NURSE DISCOVERED DURING INSPECTION THAT THE CAP WAS CRACKED AND LEAKING FLUID AND WAS NOT FUNCTIONING PROPERLY. REPLACEMENT OF THE PRODUCT COMPLETED THE TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25430558 ↗MalfunctionJun 4, 2026Leak/Splash
THE PATIENT'S SEPTUM WAS STARTED ON (B)(6) 2026 AND ON (B)(6) 2026, A SEPTUM LEAK WAS DETECTED DURING TUBE FLUSHING AT 20:00 AND THE PATIENT WAS GIVEN A NEW SEPTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402253 ↗MalfunctionMay 13, 2026Leak/Splash; Nonstandard Device
IT WAS REPORTED THAT THE Q-SYTE LEAKED. AT 8:30 A.M. ON (B)(6) 2026, A NURSE REPLACED THE Q-SYTE CONNECTOR IN ACCORDANCE WITH STANDARD OPERATING PROCEDURES. AT 9:00 A.M., DURING A ROUTINE CHECK OF THE IV INFUSION, FLUID LEAKAGE WAS DISCOVERED. THE NURSE IMMEDIATELY CONDUCTED A THOROUGH INSPECTION AND FOUND THAT THE SOFT RUBBER END CAP OF THE Q-SYTE CONNECTOR HAD COLLAPSED. UPON FURTHER CAREFUL EXAMINATION, IT WAS CONFIRMED THAT THE INTERNAL COMPONENT OF THE CONNECTOR HAD BECOME COLLAPSED AND DEFORMED. THE NURSE PROMPTLY REPLACED THE CONNECTOR WITH A NEW Q-SYTE NEEDLELESS INJECTION CAP FEATURING A SEPTUM. AFTER THE REPLACEMENT, THE INFUSION TUBING WAS RESTORED TO FULL PATENCY, AND THE PATIENT¿S TREATMENT CONTINUED WITHOUT INTERRUPTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164836 ↗MalfunctionMay 12, 2026Infusion or Flow Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153042 ↗MalfunctionApr 22, 2026Leak/Splash; Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957006 ↗MalfunctionApr 20, 2026Leak/Splash; Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932772 ↗MalfunctionApr 20, 2026Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24930508 ↗MalfunctionApr 16, 2026Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900023 ↗MalfunctionApr 11, 2026Backflow; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845946 ↗MalfunctionMar 31, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747742 ↗MalfunctionMar 19, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640649 ↗MalfunctionMar 18, 2026Leak/Splash
USED AS A NEXIVA CONNECTOR. IT WAS REPORTED THAT MEDICATION LEAKED FROM THE INFUSION LINE CONNECTION POINT DURING USE. THE CUSTOMER REQUESTS CONFIRMATION WHETHER THIS IS A PRODUCT DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631576 ↗MalfunctionMar 18, 2026Product Quality Problem
IT WAS REPORTED THAT THE Q-SYTE WAS LOOSE. "WHILE DRAWING BLOOD FROM A PATIENT'S ARTERIAL CATHETER, THE NURSE DISCOVERED THAT THE NEEDLE-FREE CLOSED-SYSTEM CONNECTOR HAD BECOME LOOSE, COMPROMISING ITS SEAL INTEGRITY AND RENDERING IT UNUSABLE. THE NURSE IMMEDIATELY REPLACED IT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626223 ↗MalfunctionMar 13, 2026Fluid/Blood Leak
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592839 ↗MalfunctionMar 10, 2026Material Rupture
SPECIFIC OPERATIONAL CIRCUMSTANCES: DURING AIR REMOVAL FOR AN IV INFUSION, AN EMERGENCY NURSE OBSERVED SEPARATION OF THE SEPTUM DISC. A NEW NEEDLE-FREE CLOSED-SYSTEM IV CONNECTOR WITH A SEPTUM WAS IMMEDIATELY REPLACED. ADVERSE EVENT DETAILS: SEPTUM DISC RUPTURE; NON-COMPLIANT CONSUMABLE. IMPACT ON AFFECTED INDIVIDUALS: POTENTIAL LEAKAGE OF INFUSION SOLUTION. INCREASED CLINICAL WORKLOAD. TREATMENT MEASURES TAKEN AND OUTCOME: IMMEDIATELY REPLACED THE SEPTUM FOR INFUSION. REPORTED THE ADVERSE EVENT AFTER TREATMENT COMPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562442 ↗MalfunctionMar 9, 2026Leak/Splash
THE NURSE OPENED THE NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH INTACT OUTER PACKAGING AND NO VISIBLE DAMAGE. WHILE FLUSHING THE LINE USING A FLUSHING TUBE CONNECTED TO THE NEEDLE-FREE CLOSED INFUSION CONNECTOR WITH A PARTITION MEMBRANE, FLUID LEAKAGE WAS OBSERVED FROM THE CONNECTOR. THE NURSE IMMEDIATELY REPLACED THE CONNECTOR WITH ANOTHER OF THE SAME BRAND, SPECIFICATION, AND BATCH NUMBER, AND RESUMED INFUSION. FLUID ADMINISTRATION PROCEEDED SMOOTHLY UNTIL COMPLETION. FIVE SIMILAR INCIDENTS INVOLVING THIS PRODUCT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550083 ↗
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-1075-2010 · Nov 6, 2009 · TerminatedMedical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
- 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-0754-2010 · Oct 19, 2009 · TerminatedMPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
- 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-0756-2010 · Oct 19, 2009 · TerminatedMPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
- 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-0755-2010 · Oct 19, 2009 · TerminatedMPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
- 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.
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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