Q-SyteRecalls & reported problems across all models

We found 6 models of Q-Syte by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2022 and May 13, 2026 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 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 Q-Syte problems

Q-Syte models

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

• Q-Syte 385158

  Set, administration, intravascular
  27 reports
• Q-Syte 385151

  Set, administration, intravascular
  25 reports
• Q-Syte 385157

  Set, administration, intravascular
  15 reports
• Q-Syte 385103

  Set, administration, intravascular
  4 reports
• Q-Syte 385161

  Set, administration, intravascular
  2 reports
• Q-Syte 385156

  Set, administration, intravascular
  1 report

Recent Q-Syte adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Manufacturing, Packaging or Shipping Problem

  "IT WAS REPORTED THAT THE PACKAGE WAS DAMAGED AND THAT AIR WAS LEAKING FROM THE PACKAGE. 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. (SEE MOVIE IN EMAIL) WHEN DID THE INCIDENT OCCUR? - BEFORE USE AS ALSO DISCUSSED OVER THE PHONE WITH KIM, WE HAVE THE FOLLOWING SITUATION BEFORE US: AN OKA NURSE SAW HER COLLEAGUE ¿STUFFING¿ BD Q-SYTE REF (B)(4) INTO A DRAWER, PRESSING THE PACKS TOGETHER AND THE AIR ¿DISAPPEARING¿. SHE PUT SOME PACKS ON HER DESK AND THEY SLOWLY FILLED BACK WITH AIR AFTERWARDS (AFTER A FEW HOURS/DAYS: BACK BULGING PACKS). I HELD THAT PACKAGING UNDER WATER AND APPLIED PRESSURE AND AIR BUBBLES EFFECTIVELY CAME THROUGH (SEE VIDEO - LOT 5307254). AFTERWARDS, I WENT TO GET A NEW PACK IN THE ECONOMIZER AND THIS PACK EFFECTIVELY CAME OUT OF THE BOX (OVERPACK), I ALSO SUBMERGED IT IN WATER AND APPLIED LIGHT PRESSURE (SO LESS PRESSURE THAN IN THE VIDEO), AIR BUBBLES CAME OUT HERE TOO. LOT NUMBER 5274103. DOESN'T SEEM OKAY TO ME?".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162651 ↗
• MalfunctionMay 13, 2026Manufacturing, Packaging or Shipping Problem

  "IT WAS REPORTED THAT THE PACKAGE WAS DAMAGED AND THAT AIR WAS LEAKING FROM THE PACKAGE. 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. (SEE MOVIE IN EMAIL) WHEN DID THE INCIDENT OCCUR? - BEFORE USE AS ALSO DISCUSSED OVER THE PHONE WITH KIM, WE HAVE THE FOLLOWING SITUATION BEFORE US: AN OKA NURSE SAW HER COLLEAGUE ¿STUFFING¿ BD Q-SYTE REF 385151 INTO A DRAWER, PRESSING THE PACKS TOGETHER AND THE AIR ¿DISAPPEARING¿. SHE PUT SOME PACKS ON HER DESK AND THEY SLOWLY FILLED BACK WITH AIR AFTERWARDS (AFTER A FEW HOURS/DAYS: BACK BULGING PACKS). I HELD THAT PACKAGING UNDER WATER AND APPLIED PRESSURE AND AIR BUBBLES EFFECTIVELY CAME THROUGH (SEE VIDEO - LOT 5307254). AFTERWARDS, I WENT TO GET A NEW PACK IN THE ECONOMIZER AND THIS PACK EFFECTIVELY CAME OUT OF THE BOX (OVERPACK), I ALSO SUBMERGED IT IN WATER AND APPLIED LIGHT PRESSURE (SO LESS PRESSURE THAN IN THE VIDEO), AIR BUBBLES CAME OUT HERE TOO. LOT NUMBER 5274103. DOESN'T SEEM OKAY TO ME?"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162643 ↗
• MalfunctionApr 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT, OVER THE WEEKEND, THERE WERE TWO INSTANCES IN WHICH THE Q-SYTE SCREW CAP CAME LOOSE FROM THE CANNULA ON ITS OWN IN TWO DIFFERENT PATIENTS. SIMILAR INCIDENTS HAVE ALSO OCCURRED ABOUT FIVE TIMES WITHIN A SHORT PERIOD OF TIME PREVIOUSLY. THE CANNULA REMAINED OPEN WITHOUT PROTECTION, POSING A RISK OF BLEEDING THROUGH THE CANNULA AND A POTENTIAL RISK OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049032 ↗
• MalfunctionApr 30, 2026Material Integrity Problem

  H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045760 ↗
• MalfunctionApr 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT, OVER THE WEEKEND, THERE WERE TWO INSTANCES IN WHICH THE Q-SYTE SCREW CAP CAME LOOSE FROM THE CANNULA ON ITS OWN IN TWO DIFFERENT PATIENTS. SIMILAR INCIDENTS HAVE ALSO OCCURRED ABOUT FIVE TIMES WITHIN A SHORT PERIOD OF TIME PREVIOUSLY. THE CANNULA REMAINED OPEN WITHOUT PROTECTION, POSING A RISK OF BLEEDING THROUGH THE CANNULA AND A POTENTIAL RISK OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045759 ↗
• MalfunctionApr 3, 2026Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781037 ↗
• MalfunctionMar 26, 2026Break

  ONE DAY AFTER THE PATIENT WAS PLACED IN THE DEVICE,THE NURSE DISCOVERED IT HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701105 ↗
• MalfunctionFeb 2, 2026Leak/Splash; Connection Problem

  INCIDENT HAPPENED IN ER DEPARTMENT WHERE AFTER CANNULATION STAFF ATTACHED QSYTE BI EXTENSION CAT NO 385157 ON IV CATHETER 18 G AND WHEN THEY TRIED TO LOCK EXTENSION BY ROTATING SPIN NUT IT GOT FREED DURING TIGHTENING OF IT WHICH RESULTED IN SPILLAGE OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235733 ↗
• MalfunctionJan 14, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075065 ↗
• MalfunctionJan 5, 2026Disconnection; Leak/Splash

  IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT SEPARATED AND LEAKED IT WAS REPORTED THAT THE PATIENT HAD A CANNULA WITH A TAILED SPIRAL Q PULSE ATTACHED TO IT. TWO DIFFERENT FLUIDS DRIPPED INTO THE CANNULA THROUGH THE Q-SYTE AT THE SAME TIME. THE CANNULA WAS PUT IN IN THE EVENING AND ITS FUNCTIONALITY WAS CHECKED DURING THE EVENING AND NIGHT AND IT WORKED FLAWLESSLY. AT NIGHT, WHEN WE WENT TO THE ROOM TO TAKE OFF THE SECOND FLUID DRIP AS PLANNED, IT WAS NOTICED THAT THE CANNULA DRESSINGS, THE PATIENT'S SHIRT AND SHEET WERE HEAVILY WET. THE CANNULA WAS PROTECTED WITH GAUZE, SO THE DRESSINGS WERE DISMANTLED AND IT WAS NOTICED THAT THE Q-CYTE HAD COMPLETELY DETACHED FROM THE CANNULA AND THE FLUIDS HAD BEEN ABLE TO LEAK PAST THE CANNULA. AS A RESULT OF THE DETACHMENT OF THE Q-SYTE, THE CANNULA NO LONGER WORKED. AS A RESULT OF THE INCIDENT, THE PATIENT HAD TO BE WOKEN UP AT NIGHT AND THE CANNULA REMOVED, AS WELL AS CHANGE INTO DRY CLOTHES AND BED SHEETS. HOWEVER, THE CANNULA DID NOT HAVE TO BE REPLACED DURING THE NIGHT, AS ENOUGH FLUIDS HAD ALREADY BEEN EMITTED. DESCRIPTION OF THE CONSEQUENCE OF THE INCIDENT OR A POSSIBLE CONSEQUENCE FOR THE PATIENT/CLIENT OR OTHER PERSON DELA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960619 ↗
• MalfunctionDec 31, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT HAD CONNECTION ISSUES AND LEAKED IT WAS REPORTED WHEN CONNECTING TO THE CATHETER, THE Q-SYTE UNSCREWS BY ITSELF, CAUSING LEAKS. WHEN DID THE INCIDENT OCCUR? DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934772 ↗
• MalfunctionDec 31, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934764 ↗
• 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 ↗
• MalfunctionDec 16, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Discomfort

  MAUDE report 23822536 ↗
• MalfunctionNov 24, 2025Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630808 ↗

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