BD Nexiva, BD Q-SyteRecalls & reported problems across all models

We found 8 models of BD Nexiva, BD Q-Syte by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,154 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2017 and Sep 29, 2026 — classified as 34 injuries, 1,120 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (457 reports).

4 FDA recall records name at least one of these models by its device identifier, 1 still open.

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

BD Nexiva, BD Q-Syte recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 8, 2021Open, Classified

   There is a breach in the product packaging that renders the product non-sterile.

   Z-0306-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Sep 14, 2020Terminated

   Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted

   Z-0125-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Mar 1, 2019Terminated

   Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

   Z-1710-2019 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

4. Aug 23, 2018Terminated

   One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.

   Z-0384-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported BD Nexiva, BD Q-Syte problems

BD Nexiva, BD Q-Syte models

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

• BD Nexiva, BD Q-Syte 383536

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls374 reports
• BD Nexiva, BD Q-Syte 383532

  Catheter,intravascular,therapeutic,short-term less than 30 days
  282 reports
• BD Nexiva, BD Q-Syte 383539

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall170 reports
• BD Nexiva, BD Q-Syte 383537

  Catheter,intravascular,therapeutic,short-term less than 30 days
  161 reports
• BD Nexiva, BD Q-Syte 383531

  Catheter,intravascular,therapeutic,short-term less than 30 days
  133 reports
• BD Nexiva, BD Q-Syte 383538

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall21 reports
• BD Nexiva, BD Q-Syte 383540

  Catheter,intravascular,therapeutic,short-term less than 30 days
  7 reports
• BD Nexiva, BD Q-Syte 383530

  Catheter,intravascular,therapeutic,short-term less than 30 days
  6 reports

Recent BD Nexiva, 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 29, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936988 ↗
• MalfunctionSep 15, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780231 ↗
• MalfunctionSep 15, 2026Crack; Fluid/Blood Leak

  No new information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780224 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak; Material Deformation; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567715 ↗
• MalfunctionJul 2, 2026Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA COMPONENT LEAKED. THE DOCTOR HAD RAISED AN ISSUE THAT THE LEAKAGE IS OBSERVED FROM THE Q SYTE ON NEXIVA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692796 ↗
• MalfunctionJun 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT BD NEXIVA ADAPTER SPLIT. DETAILED INCIDENT DESCRIPTION: WHEN A NURSE WAS ON HER WAY TO MEDICATE THE PATIENT, SHE NOTICED THAT THE QSYTE WAS SPLIT INTO TWO. THE OUTER PART OF THE CAP, WHERE THE SILICONE SEPTUM IS LOCATED, HAD NEATLY DETACHED FROM THE CANNULA, WHILE THE THREADED PORTION ATTACHED TO THE CANNULA REMAINED IN PLACE. THE CANNULA CLAMP WAS CLOSED SO THE SYSTEM REMAINED CLOSED; HOWEVER, A NEW CANNULA HAD TO BE INSERTED BEFORE MEDICATION COULD BE ADMINISTRATED. ADDITIONAL INFORMATION (E.G., PROCEDURE, DURATION OF PROCEDURE, WHETHER THE PROCEDURE COULD BE COMPLETED): THE PATIENT WAS TAKEN TO THE DOCTOR, WHERE IT WAS NOTICED THAT THE Q-PULSE VALVE WAS BROKEN. THE NEXIVA "CLIP" WAS INTACT, SO NO BLOOD CAME OUT OF THE CANNULA. THE CANNULA WAS REMOVED AND DISCARDED. A NEW CANNULA WAS INSERTED AND THE PATIENT WAS TREATED. RESPONSE RECEIVED ON: 6/24/2026 THE PATIENT HAD TO BE RECANNULATED, SO BASICALLY YES, THE PATIENT WAS HARMED. THE LOT-NUMBER WAS NOT PROVIDED SINCE IT WAS NOT WRITTEN DOWN AT THE TIME OF THE EVENT. NOT POSSIBLE TO HAVE IT AFTERWARDS. THE ISSUE IS ABOUT A NEXIVA DUAL PORT, WHERE THE QSYTE WAS INCLUDED IN THE PACKAGE. THIS QSYTE WAS THE ONE THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664524 ↗
• MalfunctionJun 26, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE ADAPTER/TUBING JUNCTION. "WHEN PLACING IV 20 GAUGE, BLOOD BACK FLOWED AS NORMAL BUT LEAKED OUT THE TUBING WHERE THE PINK ADAPTER CONNECTS." NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636230 ↗
• MalfunctionJun 25, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT BD NEXIVA LEAKED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026. WHEN YOU STATE THAT ¿WHEN THE CONTRAST WAS INJECTED ON ONE SIDE, IT CAME OUT THE OTHER,¿ IS THE CONTRAST COMING OUT OF THE SECTION WHERE THE NEEDLE IS REMOVED FROM THE WINGED CONNECTOR, FROM THE SECOND END OF THE DUAL-PORT ADAPTER AT THE TIP OF THE EXTENSION TUBE, OR FROM SOME OTHER PART OF THE DEVICE? ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 IN RESPONSE TO YOUR REQUEST, WE WOULD LIKE TO INFORM YOU THAT THERE WAS NO HARM TO THE PATIENTS INVOLVED IN THE EVENTS REPORTED. DURING THE EVENTS, IT WAS ONLY OBSERVED THAT THE PATIENTS WERE WETTED BY THE CONTRAST RESULTING FROM THE LEAK IDENTIFIED. THERE WERE NO INJURIES, CLINICAL COMPLICATIONS OR NEED FOR ADDITIONAL MEDICAL INTERVENTION. AS AN IMMEDIATE CORRECTIVE MEASURE, THE CONTRAST WAS ONLY REAPPLIED SO THAT THE EXAMS COULD BE COMPLETED PROPERLY, WITHOUT ANY FURTHER IMPACT ON THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627869 ↗
• MalfunctionJun 25, 2026Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT BD NEXIVA LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626466 ↗
• MalfunctionJun 22, 2026Leak/Splash

  IT WAS REPORTED THAT WITH A NEEDLE THE BLOOD SQUIRTED OUT OF THE IV TUBE (WHICH IS OUTSIDE THE BODY). THIS IS THE PART OF THE TUBE THAT THE NEEDLE DOES NOT PASS THROUGH. THIS IV WAS PROBABLY DEFECTIVE IN ADVANCE. HAS THIS PRODUCT ALREADY BEEN USED IN PATIENTS: YES. HAS THERE BEEN A RISK TO THE PATIENT OR USER: YES. WHAT WAS THE RISK: RISK OF CONTAMINATION THROUGH BLOOD IN, FOR EXAMPLE, EYE/MOUTH. RESPONSE RECEIVED ON 6/5/2026. TO MY KNOWLEDGE, IT HAS NOT BEEN COMMUNICATED WHERE EXACTLY THE LEAKAGE OCCURRED. I HAVE ONLY RECEIVED THE COMPLAINT DESCRIPTION AND NO PHOTO OR IMAGE INDICATING THE LOCATION OF THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587774 ↗
• MalfunctionJun 18, 2026Leak/Splash

  NURSE EDUCATOR ON ROUND OBSERVED THAT 20 G NEXIVA IS LEAKING FROM Y-PORT IN A CHEMOTHERAPY WARD WHILE FLUSHING POSSIBLY DUE TO MECHANICAL ERROR OR FAULTY CANNULA. AFTER INSERTING ANOTHER CANNULA, NO SUCH INCIDENCE RECORDED. SAFETY ISSUE: AS THE INCIDENT HAPPENED IN CHEMO WARD, THIS COULD HAPPEN WHILE ADMINISTERING THE HIGHLY VESICANT CHEMO DRUGS AND NOT JUST FLUSH. HOWEVER, THE EVENT WAS NOT FATAL, BUT SURELY A NEAR MISS AS IT CAME IN THE EYES OF MANAGEMENT AS WELL AS CLINICIANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552920 ↗
• MalfunctionJun 9, 2026Leak/Splash

  IT WAS REPORTED THAT CANNULA WAS INSERTED. ON FLUSHING LINE - LEAKAGE WAS PRESENT ON THE EXTENSION SET TUBING NEAR LUER ACCESS PORT. CANNULA WAS REMOVED AND INCIDENT REPORT FILLED OUT. PATIENT TOLD ABOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446821 ↗
• MalfunctionJun 8, 2026

  PRODUCT OKAY TO USE BUT THE DUAL PORT CAP IS LOOSE NOW AND BLOOD BACKS UP AND OUT OF LINE. NEVER DONE THAT BEFORE. CATCHES NURSE AND PATIENT OFF GUARD. THE DUAL PORT, 1 TO FLUSH LINE AND THE 2ND USED TO BE SECURE BUT IT ISN'T ANY MORE. IS THIS IN ERROR? THIS HAS HAPPENED ON SEVERAL OCCASIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426115 ↗
• MalfunctionJun 5, 2026Material Split, Cut or Torn

  MICRO TEAR OBSERVED ON THE CATHETER LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410410 ↗
• MalfunctionJun 4, 2026Leak/Splash

  IT WAS OBSERVED THAT WHEN CONTRAST WAS INJECTED THROUGH ONE ROUTE, IT WAS COMING OUT THE OTHER. NOT REACHING THE PATIENT, WETTING THE PATIENT AND THE STRETCHER. THE SITUATION WAS OBSERVED IN 2 DIFFERENT EPISODES. ADDITIONAL INFORMATION RECEIVED ON 15 MAY 2026: WAS THERE ANY HARM TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. NO DID THE SPILLED LIQUID COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROFESSIONAL¿S SKIN OR MUCOSA? IT WAS OBSERVED THAT WHEN CONTRAST WAS INJECTED THROUGH ONE ROUTE, IT WAS COMING OUT THE OTHER. NOT REACHING THE PATIENT, WETTING THE PATIENT AND THE STRETCHER. THE SITUATION WAS OBSERVED IN 2 DIFFERENT EPISODES. BECAUSE THE MATERIAL WAS CONTAMINATED, IT COULD NOT BE STORED. WE SEPARATED THE ENTIRE BATCH IN QUESTION WAS THE PROFESSIONAL WEARING PPE? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399872 ↗

Other Becton, Dickinson And Company products

• BD Vacutainer SST10 models · 4,985 reports · 3 recalls
• BD Luer-Lok48 models · 5,117 reports
• BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
• BD SafetyGlide17 models · 2,185 reports
• BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
• BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
• BD Nexiva25 models · 1,614 reports · 1 recall
• BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports