BD Q-SyteRecalls & reported problems across all models

We found 9 models of BD Q-Syte by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,322 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2017 and Sep 30, 2026 — classified as 1 death, 26 injuries, 1,295 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (764 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BD Q-Syte problems

BD Q-Syte models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Q-Syte 385100

  Set, administration, intravascular
  1 death971 reports
• BD Q-Syte 385102

  Set, administration, intravascular
  269 reports
• BD Q-Syte 385101

  Set, administration, intravascular
  27 reports
• BD Q-Syte 385163

  Set, administration, intravascular
  19 reports
• BD Q-Syte 385108

  Set, administration, intravascular
  18 reports
• BD Q-Syte 385110

  Catheter, intravascular, therapeutic, short-term less than 30 days
  11 reports
• BD Q-Syte 385162

  Set, administration, intravascular
  4 reports
• BD Q-Syte 385164

  Set, administration, intravascular
  2 reports
• BD Q-Syte 385165

  Set, administration, intravascular
  1 report

Recent BD Q-Syte adverse event reports

The 15 most recent reports across all models, 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 29, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936985 ↗
• MalfunctionSep 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921297 ↗
• MalfunctionSep 21, 2026Connection Problem; Material Integrity Problem

  "It was reported that the Q-Syte locks onto the port needle hub and cannot be detached once connected. So clinicians can not disconnect the Q-Syte from port needle hub. Sometimes while they try to disconnect, port needle hub can be broken. Therefore they have to change port needle. This is cause for extra invasive access to patient and discomfort for patients. The Q-Syte locks onto the port needle hub and cannot be detached once connected. During use."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842486 ↗
• 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 15, 2026Leak/Splash

  "It was reported that Inability to remove the Q-Syte from the catheter/port needle hub has created potential clinical risks and workflow challenges. Because the Q-Syte remains attached and cannot be removed, blood sampling is being performed through the Q-Syte rather than directly from the lumen, which is the institution's standard protocol. In addition, extra flushing is required to clear blood from the lumen and connector. There is concern that using the Q-Syte for blood sampling and/or leaving it in place longer than intended could increase the risk of infection, although no infection or patient injury has been reported. A further concern is that the Q-Syte can become firmly locked onto the port needle hub. When healthcare professionals attempt to remove it, significant force may be required, which has resulted in the port needle hub breaking. In these cases, the port needle must be replaced, requiring an additional invasive procedure for the patient. While no adverse patient outcomes have occurred so far, the need for re-accessing the port may expose the patient to an increased risk of complications, including infection, discomfort, and additional procedural intervention. In su

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775441 ↗
• MalfunctionSep 3, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591125 ↗
• 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

  ACCORDING TO THE CUSTOMER REPORT, THREE INSTANCES OF LIQUID LEAKAGE HAD OCCURRED DURING USE. THE AFFECTED PRODUCTS HAVE BEEN DISCARDED, BUT PLEASE CONFIRM WHETHER THE REMAINING PRODUCTS IN THE BOX ARE WITHIN OR OUTSIDE THE PRICE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666732 ↗
• 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 ↗

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