BD Nexiva, BD Q-Syte 383531Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 24GA 0.75IN Y · Class 2
All models of BD Nexiva, BD Q-Syte (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva IV catheter has 133 reports, many describing blood or fluid leaking from it. Some reports describe the catheter breaking off after placement, and one describes a missing piece that had to be looked for in the vein. The reports mention 8 injuries and no deaths, and no recalls name this device. Reports fell to 1 in the last 12 months from 12 in the previous 12.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 133
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00382903835317), received between Aug 7, 2018 and Mar 12, 2026 — classified as 8 injuries, 125 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (57 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash57
- Break11
- Device Contamination with Chemical or Other Material10
- Difficult or Delayed Activation9
- Defective Component8
- Fluid/Blood Leak5
- Material Protrusion/Extrusion5
- Material Puncture/Hole4
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- No Known Impact Or Consequence To Patient31
- No Consequences Or Impact To Patient8
- No Patient Involvement7
- Chemical Exposure4
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Erythema1
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Material Perforation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583341 ↗MalfunctionSep 19, 2025Activation, Positioning or Separation Problem; Material Split, Cut or Torn; Activation, Positioning or Separation Problem; Material Split, Cut or Torn
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23099475 ↗MalfunctionSep 17, 2025Material Integrity Problem; Material Integrity Problem
THE NURSE STARTED THE IV. AS SHE WAS THREADING THE IV THE NEEDLE BROKE THROUGH THE CANULA. NO INJURY TO PT. THE IV WAS REMOVED AND PATIENT AND A APOLOGY EXTENDED. NEW IV WAS STARTED ON RT HAND WITH NO ISSUES. INCIDENT DATE: (B)(6) 2025. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077036 ↗MalfunctionJul 30, 2025Contamination; Contamination
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y HAD FOREIGN MATTER RED SUBSTANCE FOUND IN CANNULA PRIOR TO INSERTION BEFORE USE RED SUBSTANCE NOTICED IN CANNULA BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666202 ↗InjuryJul 23, 2025Break; Break
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y CATHETER BROKE / SEPARATED AFTER PLACEMENT WE AGAIN HAD AN INCIDENT WITH A NEXIVA CATHETER, THIS TIME WITH ABOVE MENTIONED REFERENCE. NORMALLY MY COLLEAGUE KELLY WOUTERS IS THE ACCOUNT MANAGER OF THIS ARTICLE, BUT SHE IS ON VACATION. CAN YOU TELL ME WHAT THE NEXT STEPS ARE? CAN YOU GIVE US A BRIEF DESCRIPTION OF THE PROBLEM IDENTIFIED? AFTER PLACING THE IV CATHETER, THE PATIENT CONTINUED TO NOTICE THAT THIS CATHETER HURT A LOT. IT IS A PATIENT FOR MONTHLY IV ADMINISTRATION SO SHE HAS SOME EXPERIENCE. THEN DECIDED TO REMOVE THE CATHETER TO PLACE A NEW ONE. PART OF THE CATHETER REMAINED IN THE PATIENT, AFTER WHICH SURGICAL REMOVAL OF THE REMAINING PIECE WAS NECESSARY.
Patient problems: Foreign Body In Patient
MAUDE report 22577153 ↗InjuryJun 25, 2025Break; Defective Device; Material Integrity Problem; Break; Defective Device; Material Integrity Problem
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y CATHETER BROKE / SEPARATED AFTER PLACEMENT VERBATIM: ¿ON REMOVAL OF CANULA, PLASTIC CATHETER FOUND TO BE MISSING.? BROKEN OFF INSIDE PATIENT. DURING USE. DURING ROUTINE CANULA MANAGEMENT, LEAKAGE NOTED FROM CANULA. ON REMOVAL IT WAS NOTED THAT THE PLASTIC CATHETER WHICH SITS INSIDE THE VEIN WAS MISSING FROM THE CANULA. PATIENT HAD TO HAVE INVESTIGATIONS TO SEE IF IT REMAINED IN THE VEIN. INVESTIGATIONS DID NOT SHOW THE CATETER IN THE PATIENT BUT NURSING STAFF REMAINED CONVINCED THAT IT WASN'T THERE ON REMOVAL. UNFORTUNATELY, THE CANULA WAS NOT SAVED FOR INSPECTION.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328952 ↗MalfunctionJun 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE ACCESS WAS PUNCTURED IN THE PATIENT, THE VEIN WAS PUNCTURED AND WHEN THE SILICONE OF THE NEXIVA WAS INTRODUCED, THERE WAS EXTRAVASATION OF BLOOD IN THE CATHETER. MATERIAL (B)(6). THERE WAS AN IMPACT ON THE PATIENT DUE TO PUNCTURE, IN A NON-SERIOUS WAY. AS AN IMMEDIATE ACTION, A NEW PUNCTURE WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133470 ↗MalfunctionApr 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y LEAKED PATIENT WAS CANNULATED USING 24G BD NEXIVA CATHETER WHERE FLASHBACK OBTAINED. UPON SECURING CATHETER USING IV300 DRESSING , BLOOD WAS NOTED SEEPING FROM CATHETER FLASHBACK TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752942 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REGISTERED NURSE (RN) WENT TO PLACE PIV WITH NEXIVA 24 G. X 0.75 IN. PERIPHERAL INTRAVENOUS (PIV) WAS SUCCESSFULLY PLACED, BUT WHEN RN WENT TO FLUSH THE LINE, THE "PIGTAIL" WAS LEAKING "EVERYWHERE". RN REMOVED THE PIV AND SUCCESSFULLY RESTARTED NEW PIV. (B)(6)2025 CUSTOMER RESPONSE: PLEASE PROVIDE THE DATE OF EVENT FOR (B)(6)2025. 01/21/2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21403700 ↗MalfunctionJan 27, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21242574 ↗MalfunctionJan 3, 2025Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT BD NEXIVA THREADING TREADING FAULTY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITUATION: ISSUE: THE IV SET WAS FAULTY, LEAKING AT THE MAINLINE PORT. TIGHTENING CAPS DID NOT WORK BECAUSE THE THREADING WAS FAULTY. IV HAD TO BE REMOVED AND PT HAD TO BE STUCK AGAIN FOR IV INSERTION. BACKGROUND: EVENT DATE: 12/6/2024. IH #: 80011227. MFG #: 383531. DESCRIPTION: CATH IV NEXIVA 24GAX.075 383531. SAMPLE AVAILABLE: YES (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL, AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL) LOT #: 4178005. ASSESSMENT: CREDIT REQUESTED: NO. PO # 82528. WAS THERE INJURY? NO. NAME OF FACILITY: XXX. MAIN CONTACT NAME AND EMAIL ADDRESS: XXX. FRONTLINE CAREGIVERS CONTACT INFORMATION (IF APPLICABLE): NA. ACCOUNT # PO PURCHASED ON: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067949 ↗MalfunctionDec 12, 2024Material Puncture/Hole; Material Puncture/Hole
NEEDLE OF THE DEVICE IS EXTERNALIZED, GOING BEYOND THE SAFETY CASING AND PUTTING PROFESSIONALS AT RISK OF PUNCTURING THEMSELVES. THE OUTER PACKAGING HAS NOT BEEN DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913320 ↗MalfunctionDec 10, 2024Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894245 ↗MalfunctionOct 22, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT BD NEXIVA NEEDLESS CONNECTOR FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN SALINIZING THE AVP OF THE NEXIVA 24, THE SECOND CONNECTOR COMES OFF DUE TO THE FLOW AND NEEDS TO BE REPLACED WITH A NEW CONNECTOR. MATERIALS UNAVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 27 SEP 2024: IS THERE ANY OTHER IMPACT TO PATIENT, IF YES DESCRIBE IN DETAIL. THERE WAS NO IMPACT ON THE PATIENT. WAS THERE ANY PHYSICAL DAMAGE / DEFECT FOUND IN THE PRODUCT? WE DO NOT HAVE THIS INFORMATION. WAS ANOTHER DEVICE REQUIRED/USED TO COMPLETE THE PROCEDURE? YES. HOW WAS THE PROCEDURE COMPLETED? THE CONNECTOR HAD TO BE REPLACED. COULD YOU PLEASE SHARE ANY PHOTO SAMPLE RELATED TO THIS EVENT? UNFORTUNATELY WE DON'T HAVE A PHOTO OR A SAMPLE, AS IT WAS NECESSARY TO DISPOSE OF IT DUE TO CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507095 ↗MalfunctionOct 14, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y 'CAP' FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONCERN DESCRIPTION: REGULARLY STOCKED IV SYSTEM WE USE ISLAND HEALTH WIDE FOR YEARS. THE ATTACHED CAPS ALWAYS COME LOOSE AND NOT FULLY TIGHTENED, IS THERE ANYWAY FOR THE MANUFACTURER TO FULL TIGHT PRE ATTACHED CAP? DATE OF INCIDENT: (B)(6) 2024. CONCERN DESCRIPTION: REGULARLY STOCKED IV SYSTEM WE USE ISLAND HEALTH WIDE FOR YEARS. THE ATTACHED CAPS ALWAYS COME LOOSE AND NOT FULLY TIGHTENED, IS THERE ANYWAY FOR THE MANUFACTURER TO FULL TIGHT PRE-ATTACHED CAP? NO ADVERSE EVENT REPORTED. I HAVE NO UPDATES. IN THE PRODUCT COMPLAINT I EXPLAIN VERY CLEARLY THE ATTACHED Y-SITE CAP FOR THE NEXIVA IV¿S IS ONLY PARTIALLY TIGHTENED WHEN REMOVED FROM THE PACKAGING. THIS CAP FELL OFF FOR A NURSE WHEN THEY WERE INSERTING AN IV INTO A PATIENT, AND HAD THEY NOT NOTICED THE PATIENT WOULD HAVE BLED EXTENSIVELY FROM THE OPEN PORT. THIS HAS HAPPENED MULTIPLE TIMES AT OUR SITE TO DIFFERENT NURSES, AND IN ALL MY TIME OF USING THE NEXIVA IV¿S HAS BEEN AN ISSUE SINCE THEY WERE ROLLED OUT. MY STAFF WERE JUST WONDERING IF IT WAS POSSIBLE FOR THE PRE-ATTACHED Y-SITE CAP TO COME PROPERL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440296 ↗MalfunctionOct 9, 2024Disconnection; Disconnection
IT WAS REPORTED THAT BD NEXIVA UNABLE TO CONNECT TUBING TO Q-SYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN INSTALLING AN ANTINEOPLASTIC, THE SPIROS CONNECTOR THAT COMES WITH THE EQUIPMENT DID NOT CONNECT TO NEXIVA 24. UNAVAILABLE MATERIAL, PLEASE FIND ATTACHED THE VIDEO WE HAVE. ADDITIONAL INFORMATION RECEIVED. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20413166 ↗MalfunctionSep 18, 2024Material Separation; Material Separation
IT WAS REPORTED THAT BD NEXIVA TUBING SEPARATED FROM THE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE INSERTED THE PERIPHERAL NEXIVA CATHETER INTO PATIENT¿S VEIN SUCCESSFULLY. WHEN ATTEMPTED TO FLUSH THE CATHETER, THE EXTENSION TUBING DISCONNECTED FROM THE HARD CASED OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246827 ↗MalfunctionJun 21, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT BD NEXIVA, UNABLE TO REMOVE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON THE CANNULA GOING INTO THE PATIENT, THE NURSE WAS UNABLE TO REMOVE THE INTRODUCER (METAL NEEDLE).
Patient problems: Insufficient Information
MAUDE report 19586237 ↗MalfunctionJun 20, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT BD NEXIVA 24GA 0.75IN Y NEEDLE DISENGAGEMENT (REMOVAL) WAS DIFFICULT JUST TO KEEP YOU INFORMED THAT TODAY WE CAME ACROSS AN ISSUE WITH AN NEXIVA 24GA CANNULA (BN 3114096). UPON THE CANNULA GOING INTO THE PATIENT THE NURSE WAS UNABLE TO REMOVE THE INTRODUCER. (METAL NEEDLE). THE CANNULA WAS REMOVED AND A NEW CANNULA WITH A DIFFERENT BATCH NUMBER WAS USED WITH NO ISSUE. THE REST OF THE CANNULA'S WITH THE SAME BATCH NUMBER WERE REMOVED FROM USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19577210 ↗MalfunctionJun 7, 2024Material Separation; Material Separation
IT WAS REPORTED THAT BD NEXIVA, TUBING SEPARATED FROM ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS RECEIVING TAXOL VIA LEFT IVL IN THE UNDERARM. TUBING FROM THE PLASTIC IV INSERTION SNAPPED OFF LEADING TO CHEMO AND BLOOD SPILL ONTO PATIENT'S LEFT RIB AND LEFT HIP. NO IRRITATION PRESENT ON SKIN AND PATIENT ENDORSED FEELING OKAY. NO ADVERSE EVENT OR SERIOUS INJURY REPORTED. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19486024 ↗MalfunctionMay 24, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD NEXIVA NEEDLE PIERCED THE CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA 24 GAUGE -AS RN WAS TRYING TO ACCESS PATIENT¿S VEIN THE NEEDLE CAME AWAY FROM THE PLASTIC CATHETER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19392723 ↗MalfunctionApr 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD NEXIVA HAD CONDENSATION WITHIN THE UNIT PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE VALUE ANALYST TEAM AT NYU RECEIVED A REPORT ABOUT THE BD NEXIVA KIT 24 GA. THE REPORT STATES THAT ¿BD NEXIVA KIT 24 GA FOUND IN CLEAN SUPPLY ROOM THAT WAS INTACT BUT APPEARS TO HAVE CONDENSATION. THIS WAS THE ONLY KIT AFFECTED (THE OTHER KITS WERE CHECKED).¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19048080 ↗MalfunctionFeb 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THIS IS A REPORT ABOUT FOREIGN MATTER ON NEXIVA. ACCORDING TO THE CUSTOMER'S REPORT, INK LIKE SCATTERED STAINS ON THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794637 ↗MalfunctionJan 22, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
DURING INSERTION, HE NOTICED THAT THE CATHETER WAS CRACKED. ADDITIONAL INFORMATION RECEIVED ON 4-JAN-2024 :-PATIENT HAS BEEN IMPACTED AND CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18554102 ↗MalfunctionJan 10, 2024Break; Break
UPON INSERTING THE CANNULA INSIDE THE PATIENT'S VIEN I TRIED TO REMOVE THE METAL NEEDLE BUT IT WONT BUDGE, AND REMOVED THE ENTIRE CANNULA FOR SAFETY REASONS BECAUSE THE NEEDLE PART IS BROKEN AND WONT BUDGE. DURING INSERTION AND DURING REMOVAL THE METAL NEEDLE WONT BUDGE, AND NEEDLE WAS BROKEN AND WOULD NOT BUDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489184 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page