BD Q-Syte 385163Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00382903851638), received between Oct 11, 2019 and Sep 21, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionMay 26, 2026Packaging Problem

  "IT WAS REPORTED THAT AIR IN PACKAGING WHEN DID THE INCIDENT OCCUR? BEFORE USE WHILE STORING THE PRODUCTS, THE PACKAGING WAS SQUEEZED, WHAT MADE THEM NOTICE THAT IT REALLY COLLAPSED: AIR WAS LEAVING THE PACKAGE. THEY DID A WATER TEST, AND BUBBLES CAME OUT OF THE PACKAGE. SAME PROBLEM AS PIR (B)(4)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284333 ↗
• MalfunctionMay 26, 2026Packaging Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281064 ↗
• MalfunctionFeb 9, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SET BROKE INSIDE THE HICKMANN CATHETER DURING USE AND WAS REMOVED WITH A WRENCH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY 13.01 WE HAD TWO CHILDREN WITH A HICKMANN CATHETER. IN BOTH CASES THE CONNECTED INFUSION SYSTEM BROKE INSIDE THE HICKMANN CATHETER. IN ONE CASE, THE SURGEON WAS ABLE TO REMOVE THE PART USING A WRENCH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330813 ↗
• MalfunctionFeb 9, 2023Break; Break

  IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SET BROKE INSIDE THE HICKMANN CATHETER DURING USE AND WAS DIFFICULT TO REMOVE, HAVING TO BE CUT AND RENEWED WITH A REPAIR SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY 13.01 WE HAD TWO CHILDREN WITH A HICKMANN CATHETER. IN BOTH CASES THE CONNECTED INFUSION SYSTEM BROKE INSIDE THE HICKMANN CATHETER... IN THE SECOND CASE THE HICHMANN CATHETER HAD TO BE CUT AND RENEWED WITH A REPAIR SET, WHICH WAS A LOT OF WORK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330782 ↗
• MalfunctionAug 9, 2022Free or Unrestricted Flow; Air/Gas in Device; Free or Unrestricted Flow; Air/Gas in Device

  IT WAS REPORTED THAT WHILE USING THE BD Q-SYTE¿ NEEDLE-FREE CONNECTOR BUBBLES WERE RELEASED AT THE CONNECTION TO THE PIPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: THE NURSE REPORTED TO ME THAT BUBBLES WERE RELEASED AT THE CONNECTION TO THE PIPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191018 ↗
• MalfunctionAug 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD Q-SYTE¿ NEEDLE-FREE CONNECTOR CHEMO LEAKED ON THE PATIENT'S HAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER MENTIONED THAT MEANWHILE, THEY HAVE RECEIVED A SECOND NOTIFICATION FOR THE IDENTICAL REFERENCE (B)(4) NEGATIVE CONSEQUENCES FOR THE PATIENT, CHEMO ENDED UP ON THE PATIENT'S HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191017 ↗
• MalfunctionJul 29, 2022Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SET HAD AIR BUBBLES IN THE LINE AND LEAKED AT THE CONNECTION TO THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "THE NURSE REPORTED TO ME THAT BUBBLES WERE RELEASED AT THE CONNECTION TO THE PIPE... YES LEAKAGE WAS IDENTIFIED (WET= LEAKAGE!)"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136343 ↗
• InjuryApr 18, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED 3 BD Q-SYTE¿ BI-EXTENSION SETS HAD LEAKAGE ISSUES, RESULTING IN A SECOND CHEMO DOSE BEING NECESSARY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD Q-SYTE BI-EXTENSION SET WAS LEAKING (THREE INCIDENCES) WHILE CONNECTED TO A PORT NEEDLE (POLYFLON MAKE FROM COMPETITOR)THIS HAPPENED WHILE INFUSING CHEMO USING AN INFUSION PUMP."

  Patient problems: Insufficient Information

  MAUDE report 14135538 ↗
• MalfunctionFeb 2, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHEN USING THE BD Q-SYTE¿ NEEDLE-FREE CONNECTOR WITH SMALL BORE BI-EXTENSION SET , THE DEVICE EXPERIENCED AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN REPORTED OCCLUSION WAS OBSERVED? ON (B)(6) 2022. HOW WAS THE PROCEDURE FINISHED? AFTER OCCLUSION IT WAS SIMPLY STOPPED CUSTOMER REPORTED OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423011 ↗
• MalfunctionJan 21, 2022Break; Break

  IT WAS REPORTED THAT BD Q-SYTE BI-EXTENSION SET 15 CM (6 IN) 0.45 ML WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN UNSCREWING THE THREAD OF THE OCTOPUS, IT BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13319654 ↗
• MalfunctionDec 3, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SET OCTOPUS PIECE BROKE AND CAUSED PROSTIN TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "OCTOPUS PIECE BROKEN OFF IN ORANGE LUMEN OF CL CAUSING LEAKAGE OF PROSTIN." "DID THE DEFECT AFFECT A PATIENT? MORE OR LESS. THE MEDICATION (PROSTIN) THAT WAS RUNNING HAD TO BE DOUBLED. THE QUESTION IS WHETHER THIS HAD TO BE DONE ANYWAY OR WHETHER IT WAS DUE TO THE LEAKAGE OF THE INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923373 ↗
• MalfunctionJul 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BI-EXT SET 15CM SMALL BORE SPIN NUT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING ADMINISTRATION OF CHEMO (CISPLATIN), LEAKAGE AT THE LEVEL OF QSYTE. MRS. HAD LIQUID (CHEMO) ON HER GARMENT, FURTHER WORKED ACCORDING TO PROCEDURE.

  Patient problems: Chemical Exposure

  MAUDE report 12147374 ↗
• MalfunctionMar 3, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SETS CONNECTION TO THE SYRINGE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "BROKEN 5 ML SYRINGE FROM SET Q-SYTE (OCTOPUS)." "AFTER INVESTIGATING THE COMPLAINT MATERIAL, WE CAME TO THE CONCLUSION THAT IT WAS NOT THE 5ML SYRINGE BUT THE CONNECTION OF ONE OF THE Q SYTES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402999 ↗
• MalfunctionDec 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BI-EXT SET 15CM SMALL BORE SPIN NUT WAS FOUND TO BE DEFECTIVE BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "1 Q-SYTE APPEARS TO BE DEFECTIVE, IT IS OBSTRACTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11066234 ↗
• MalfunctionJan 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE ACACIA EXTENSION SETS W/ BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM DEVICE THERE WAS AN ISSUE WITH LEAKAGE WITH THE Q SYTE DEVICE DETACHED FROM THE EXTENSION WHILE CONNECTED TO THE ADMINISTRATION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE Q SYTE DEVICE DETACHED FROM THE EXTENSION WHILE CONNECTED TO THE ADMINISTRATION SET. THIS HAPPENED DURING A SURGICAL PROCEDURE IN THEATER AND WAS ONLY REALIZED LONG AFTER ALL THE FLUIDS AND IV DRUGS HAD DRAINED INTO THE LINEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9546061 ↗
• MalfunctionOct 11, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT ACACIA EXTENSION SETS W/ BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM DEVICE WAS HAVING FLOW ISSUES. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER EASILY DETACHING, DIFFICULTY IN FLUSHING & ALLOWING BACK FLOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178496 ↗