Q-Syte 385103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903851034), received between May 14, 2024 and Dec 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT BD Q-SYTE LEAKED. QSYTE IS LEAK AND BREAK FROM INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828503 ↗
• MalfunctionJul 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD Q-SYTE HAS INCORRECT LABEL INFORMATION. THE MANUFACTURING DATE IS DIFFERENT IN THE PRODUCT PACK FROM THE DATE IN COA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838978 ↗
• MalfunctionJul 16, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD Q-SYTE - STANDALONE INDIA SEPTUM DAMAGED IDENTIFIED DURING DEVICE INVESTIGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ATTACHED NEW Q-SYTE STAND ALONE, BLOOD ENTERS BELOW THE SEPTUM AREA, EVEN AFTER FLUSHING, BLOOD STUCK AS IT IS. NO COURSE OF TREATMENT CHANGED. PHARMACY REPLACE THE PARTICULAR UNIT. INVESTIGATION FINDING: SEPTUM DAMAGE LEAD TO OBSERVED LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752128 ↗
• MalfunctionMay 14, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313195 ↗

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 · Terminated
  BD 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 · Terminated
  Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
• Z-1075-2010 · Nov 6, 2009 · Terminated
  Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
• Z-1073-2010 · Nov 6, 2009 · Terminated
  Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
• Z-0751-2010 · Oct 19, 2009 · Terminated
  BD 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 · Terminated
  MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
• Z-0753-2010 · Oct 19, 2009 · Terminated
  BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0756-2010 · Oct 19, 2009 · Terminated
  MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
• Z-0750-2010 · Oct 19, 2009 · Terminated
  BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0752-2010 · Oct 19, 2009 · Terminated
  BD 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 · Terminated
  MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,