BD Nexiva, BD Q-Syte 383538Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20GA 1.75IN HF Y · Class 2
All models of BD Nexiva, BD Q-Syte (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903835386), received between Jun 5, 2018 and May 11, 2026 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (9 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Sep 14, 2020Class IITerminated
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 ↗
Most reported problems
Device problems
- Leak/Splash9
- Material Separation4
- Break3
- Device Contamination with Chemical or Other Material3
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient6
- Hemorrhage/Blood Loss/Bleeding2
- Injury1
- Insufficient Information1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145224 ↗MalfunctionMay 11, 2026Leak/Splash
IT WAS REPORTED THAT THE TUBING LEAKED AT THE ADAPTER-TUBING JUNCTION. "IT WAS REPORTED THAT TODAY ULTRASOUND GUIDED IV WAS INSERTED IN THE ABOVE PATIENT. THE IV WAS CORRECTLY PLACED, BUT AFTER PLACING THE IV THE IV SYSTEM TURNED OUT TO BE LEAKY. BLOOD LEAKS UP THE END OF THE TUBE, JUST BELOW THE JUNCTION WHERE FLUIDS CAN BE ADMINISTERED.". "THE RISK FOR THE PATIENT IS THAT THE CHANCE OF A RUNNING IV IS SMALLER, BECAUSE THESE PATIENTS HAD ALREADY BEEN PRICKED WITH THE ULTRASOUND AND IF THE LEAKAGE WERE NOT SEEN, MEDICATION WOULD NOT REACH THE PATIENT. ".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145164 ↗MalfunctionSep 2, 2025Material Separation; Material Separation
MalfunctionAug 11, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD NEXIVA CATHETER SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAD A VERY UNFORTUNATE EVENT HAPPEN TO A PT YESTERDAY WHO WAS COMING IN A SENSITIVE ISSUE THE NURSES POKED HER 2 TIMES THEN CALLED US. I SUCCESSFULLY PLACED A 20 G 1.75 WENT TO FLUSH IT AND NOTICED BLOOD RUNNING DOWN HER ARM. I TOOK THE DRESSING OFF AND NOTED THAT THE IV TUBING WAS COMPLETELY SEPARATED FORM WINGS OF THE CATHETER. YES, AN ADVERSE EVENT HAPPENED. PT HAD PREVIOUSLY BEEN POKED 2 TIMES BEFORE THEY CALLED US. I SUCCESSFULLY PLACED A 20 G 1.75 WENT TO FLUSH IT AND NOTICED BLOOD RUNNING DOWN HER ARM. I TOOK THE DRESSING OFF AND NOTED THAT THE IV TUBING WAS COMPLETELY SEPARATED FORM WINGS OF THE CATHETER. THE PATIENT WAS EXTREMELY UPSET THAT NOT ONLY HAD SHE BEEN POKED NOW 3 TIMES, BUT WE NEEDED TO POKE HER AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777946 ↗MalfunctionJul 9, 2024Stretched; Stretched
IT WAS REPORTED THAT BD NEXIVA DUAL PORT Q-SYTE TUBING BALLOONED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SYSTEM IS NOT LETTING ME ACCESS THE SAFETY FILE, BUT BASICALLY WE HAD A NEXIA 20G IV THAT SWELLED WHEN FLUSHED, WHICH OBVIOUSLY CAUSE THE PATIENT QUITE A BIT OF PAIN. HARD TO FLUSH, SWELLING IN PATIENTS ARM.
Patient problems: Pain; Swelling/ Edema
MAUDE report 19705613 ↗MalfunctionMay 24, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19397590 ↗MalfunctionJan 12, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BD NEXIVA 20GA 1.75IN HF Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLOOD LEAKING FROM CONNECTION OF HUB AND STABILIZATION WINGS IMMEDIATELY AFTER INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18506339 ↗MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18350966 ↗MalfunctionFeb 3, 2022Defective Component; Defective Component
IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT HAD THE CATHETER ADAPTER DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "Q-SYTE NEEDLESS CONNECTOR THAT COMES IN PRODUCT PACKAGING IS NOT ALLOWING A SYRINGE TO BE PLACED ON END OF IT ON SEVERAL DIFFERENT OCCASIONS. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13444103 ↗MalfunctionJan 7, 2022Break; Break
IT WAS REPORTED THAT THE BD NEXIVA¿ DUAL PORT CLOSED IV CATHETER SYSTEM WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ISSUE WITH BEVEL OR CATHETER AT LEVEL OF TRANSITION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13196774 ↗MalfunctionNov 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BD NEXIVA¿ DUAL PORT CLOSED IV CATHETER SYSTEM CAP SEPARATED FROM THE SECOND PORT DURING THE CT INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS USING THE NEXIVA DUAL PORT AND THE CAP HAS POPPED OF THE 2ND PORT THE LAST COUPLE OF TIMES THAT THEY'VE USE IT FOR CT INJECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12857110 ↗MalfunctionSep 21, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT NEXIVA 20GA 1.75IN HF Y NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A DELIVERY OF SOME DEFECTIVE PRODUCTS. THE ENTIRE BOX FROM THIS DELIVERY IS UNUSABLE AND I ALSO HAVE 10 EACH FROM AN EARLIER DELIVERY, BUT NOT SURE WHAT PO IT WOULD HAVE BEEN ON. NOT SURE IF IT¿S ENTIRELY CLEAR FROM THE PHOTOS BUT THE PACKAGING APPEARS TO HAVE BEEN MELTED AND IN A NUMBER OF CASES HAS SPLIT OPEN DUE TO WARPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12508237 ↗MalfunctionJul 21, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD NEXIVA¿ DUAL PORT CLOSED IV CATHETER SYSTEM NEEDLE TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DULL NEEDLE ON SPECIFIC LOT." VIA BD INVESTIGATION: "THE FAILED SAMPLES WERE THEN INSPECTED WITH A MICROSCOPE AND NEEDLE DAMAGE WAS FOUND AT THE TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12208040 ↗MalfunctionJun 22, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT CATHETER STAYED IN VEIN AND SPLIT FOLLOWING INSERTION AND HEMORRHAGE OCCURRED UPON REMOVAL OF NEEDLE WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANULA THAT STAYS IN THE VEIN FOLLOWING INSERTION HAD A SPLIT. PT BLED FROM THIS SITE IMMEDIATELY UPON REMOVAL OF THE NEEDLE. ADDITIONALLY, ON 2020-06-06 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WHAT IS THE BATCH NUMBER? WAS THERE SERIOUS INJURY? NO, PT BLED A BIT AND A NEW IV HAD TO BE INITIATED. WERE THERE ERRONEOUS RESULTS? NO. DID THE COURSE OF TREATMENT CHANGE? NO. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? YES, TO THE RN. SHE WAS WEARING GLOVES. WAS THERE MEDICAL INTERVENTION? BLEEDING WAS CONTROLLED BY REMOVING THE CATHETER AND PUTTING PRESSURE ON THE PUNCTURE SITE. WERE THERE ANY OTHER ACTIONS TAKEN? REPORTED INCIDENT TO THE PATIENT CARE COORDINATOR.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10182011 ↗InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS - DUAL PORT 20 GA 1.75 IN WERE INVOLVED IN A SERIOUS INJURY IN THE FORM OF A CHANGE IN THE COURSE OF TREATMENT DURING USE. DUE TO PAINFUL APPLICATION, MULTIPLE PATIENTS HAVE REQUESTED TO HAVE THE PLACEMENT OF THEIR IV STOPPED. IT HAS NOT BEEN SPECIFIED WHETHER ALTERNATIVE MEDICAL TREATMENT/INTERVENTION WAS SOUGHT OR RECEIVED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383538, BATCH NO.: 9325212. PER EMAIL: SO I JUST MESSED WITH THE 20G. IT FEELS LIKE THERE'S A LITTLE LIP ON THE TIP OF THE NEEDLE. IF YOU RUN SOMETHING OVER THE TIP YOU CAN FEEL IT CATCH. IT'S NOT LIKE THAT ON THE 22'S. NEXIVA NEEDLES 20G 1.75" HAVE BEEN REALLY DULL LATELY. LAST FEW BOXES WE'VE HAD. THE LOT NUMBER 9325212. HELP!!!! THIS ISN'T OK FOR OUR VETS! VERY PAINFUL FOR THE PATIENT. MULTIPLE HAVE REQUESTED STOPPING THE PLACEMENT OF IV.
Patient problems: Injury
MAUDE report 9923844 ↗MalfunctionMar 11, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A POPPING NOISE WAS FOUND DURING USE WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN ATTEMPTING TO STICK A PATIENT THERE IS LIKE A POP WHERE THE NEEDLE PUSHES BACK INSIDE THE CATHETER LUMEN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9819344 ↗MalfunctionFeb 17, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING USE, THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM PRODUCED A "POP" WHERE THE NEEDLE PUSHED BACK INTO THE CATHETER LUMEN, AND FAILED TO PUNCTURE THE PATIENT'S SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I MYSELF, AND FELLOW COWORKERS BEGAN EXPERIENCING ISSUES WITH THESE IVS ON FRIDAY. THOUGH I HAVE NOT EVER EXPERIENCED THIS ISSUE BEFORE, WHEN ATTEMPTING TO STICK A PATIENT, THERE IS LIKE A POP WHERE THE NEEDLE PUSHES BACK INSIDE THE CATHETER LUMEN; CONSEQUENTLY, WE ARE LEFT WONDERING "WHY ISN'T THIS PUNCTURING THE SKIN." IT IS ALMOST LIKE THE NEEDLE IS DULL."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716887 ↗MalfunctionJul 11, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA DUAL PORT 20GA 1.75IN (1.1 MM X 45 MM) EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383538, BATCH NO: 8186541. PER CUSTOMER EMAIL: HEY, ANOTHER ONE DISCONNECTED OR BROKE APART WHEN USED ON A PATIENT. ITEM NUMBER (383538), LOT NUMBER (8186541).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8782106 ↗MalfunctionApr 29, 2019Break; Material Separation
MATERIAL NO: 383538, BATCH NO: 8186541. IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE CATHETER BROKE APART FROM THE INSERTER WHEN INSERTED INTO A PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION PER ATTACHED CUSTOMER EMAIL STATES, "HEY ¿ WE HAD A 20G NEXIVA CATH BREAK APART WHEN INSERTED IN A PATIENT IN THE ED. PART # 383538 ¿ LOT # 8186541. I HAVE IT IN MY OFFICE. I KNOW YOU ARE OUT OF TOWN SO WILL HOLD ON TO IT ¿ JUST LET ME KNOW HOW YOU WANT TO GET IT.". DURING FOLLOW UP CALL WITH CUSTOMER 04/10, THE EVENT DATE WAS PROVIDED AND CLARIFICATION WAS OBTAINED ABOUT THE LOCATION OF WHERE THE CATHETER SEPARATED (FROM INSERTER). CUSTOMER ALSO STATED THAT NO MEDICAL INTERVENTION WAS NEEDED AND ONLY ADDITIONAL ACTION TAKEN WAS HAVING TO RESTICK THE PATIENT. THERE WAS BLOOD EXPOSURE, BUT THE STAFF MEMBER WAS WEARING PPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8560633 ↗MalfunctionOct 15, 2018Material Separation
IT WAS REPORTED THAT THE EXTENSION SET SEPARATED FROM THE CONNECTION WITH THE BASE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7965607 ↗MalfunctionJun 5, 2018Detachment Of Device Component
IT WAS REPORTED WITH THE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH TUBING SEPARATION. IT WAS STATED ¿AT TIME OF INSERTION OF THIS PIV, WHEN FLUSHING THE INTEGRATED INTENSION TUBING WAS NOT FULLY CONNECTED AT POINT OF ENTRY.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7570731 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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