BD Nexiva, BD Q-Syte 383539Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 18GA 1.25IN HF 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 is a short-term catheter used to place IV lines. Of its 170 reports, most describe blood or fluid leaking or splashing from the catheter and tubing, and the reports mention no deaths or injuries. The catheter has 1 recall, from August 2018, which is closed; it covers one lot with a needle tip shield that did not work as intended, which can raise the risk of needlestick injury.
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
- 170
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00382903835393), received between Nov 3, 2017 and Jun 22, 2026 — classified as 170 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (86 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
- Aug 23, 2018Class IITerminated
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 problems
Device problems
- Leak/Splash86
- Fluid/Blood Leak26
- Detachment of Device or Device Component7
- Break6
- Defective Component6
- Material Puncture/Hole6
- Detachment Of Device Component5
- Retraction Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- No Known Impact Or Consequence To Patient37
- Insufficient Information9
- No Consequences Or Impact To Patient9
- Pain3
- Exposure to Body Fluids1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionMar 13, 2026Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24595104 ↗MalfunctionMar 13, 2026Material Puncture/Hole
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24595103 ↗MalfunctionJan 14, 2026Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075066 ↗MalfunctionDec 22, 2025Leak/Splash; Leak/Splash
GIVE A COMPLAINT DESCRIPTION: GREEN DRIP, WAS LEAKING SO THAT BLOOD SPURTED DIRECTLY FROM THE HOSE. HAS THIS PRODUCT ALREADY BEEN USED IN PATIENTS : YES HAS THERE BEEN A RISK TO THE PATIENT OR USER : YES NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871472 ↗MalfunctionDec 14, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799471 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT BD UNKNOWN NEXIVA DIFFUSICS SEPARATION ADAPTER FROM TUBING. IT WAS REPORTED BY CUSTOMER THAT WE HAD ONE BREAK APART WHILE IN A PATIENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. FOR PRODUCT #: 383539 CATHETER NEXIVA CLOSED IV DUAL PORT 18 GA 1.25 IN UI# (B)(4), WE HAD ONE BREAK APART WHILE IN A PATIENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768122 ↗MalfunctionNov 18, 2025Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589132 ↗MalfunctionNov 4, 2025Material Puncture/Hole; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466641 ↗MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole
(B)(6) 2025. THERE WAS NO INJURY, BUT THE PATIENT DID REQUIRE A RE-STICK FOR ANOTHER IV SITE (BOTH TIMES), AND WE USE 18-GAUGE IV CATHETERS, WHICH CAN BE UNCOMFORTABLE FOR INSERTION. ADDITIONALLY, WITH A WELL-FUNCTIONING IV SITE AND A LARGE GAUGE, THERE WAS A SIGNIFICANT AMOUNT OF BLOOD FLOWING DUE TO A DEFECT IN THE TUBING, WHICH UNNECESSARILY EXPOSED THE STAFF MEMBER TO A CONSIDERABLE VOLUME OF BLOOD. THE PATIENT HAD NO SERIOUS INJURY AND HAD A WORKING IV SITE FOR HER INDUCTION OF LABOR FOR THE DAY. THE NURSE DID NOT HAVE ANY DIRECT CONTACT WITH BLOOD OTHER TO HER GLOVED HANDS AND SCRUBS WHICH SHE WAS ABLE TO CHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23432193 ↗MalfunctionOct 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PRODUCT FAULT: BLOOD SPURTING OUT FROM CANULA. DURING USE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23319729 ↗MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: #18 GAUGE IV INSERTED IN PATIENT, WHEN NEEDLE WAS RETRACTED BACK AND REMOVED BLOOD LEAKED FROM THE HUB. IV REMOVED AND NEW IV PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613773 ↗MalfunctionJul 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 18GA 1.25IN HF LEAKED DEFECTIVE NEXIVA G18 BLOOD PASSING THROUGH PUSHTAB UPON IV INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384664 ↗MalfunctionApr 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: ON (B)(6) 2024 CONCERN DESCRIPTION: THERE WAS BLOOD COMING OUT OF THE PORT WHERE THE NEEDLE IS REMOVED FROM. IT IS A ONE-WAY VALVE AND SHOULD SEAL OFF WHEN THE NEEDLE IS REMOVED. WHEN THE IV WAS FLUSHED THE SALINE ALSO COME OUT OF THIS PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21931240 ↗MalfunctionApr 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: #18 GAUGE IV INSERTED IN PATIENT, WHEN NEEDLE WAS RETRACTED BACK AND REMOVED BLOOD LEAKED FROM THE HUB. IV REMOVED AND NEW IV PLACED. (B)(6) 025 THE ONLY NEGATIVE OUTCOME WAS THAT THE I.V. NEEDED TO BE REINSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887074 ↗MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash
MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash
MalfunctionJan 27, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21248306 ↗MalfunctionJan 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21248303 ↗MalfunctionJan 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA LEAKED FROM FLASH CHAMBER AFTER RETRACTION (B)(6) 2024: HI, THE INFORMATION YOU HAVE REQUESTED IS AS FOLLOWS- THE NURSE HAD TO STICK A PATIENT 3 DIFFERENT TIMES, ALL 3 AS SOON AS SHE GOT THE CATH INSERTED BLOOD SHOT OUT ALL OVER THE PLACE. THE IMPACT ON THE PATIENT AND PATIENT CARE FROM THIS INCIDENT WAS THE PATIENT AT THAT POINT WOULDN'T ALLOW THE NURSE TO TRY AGAIN. SO, THE PATIENT DIDN'T RECEIVE THE IV FLUIDS THE DOCTOR ORDERED IS MY UNDERSTANDING. I DO HAVE ONE OF THE ACTUAL CATHS THAT WAS USED SEALED IN A BIO-BAG IN CASE IT WAS NEEDED FOR INSPECTION. THANKS FOR YOUR HELP ON THIS MATTER.
Patient problems: Insufficient Information
MAUDE report 21091901 ↗MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV PLACED ON PATIENT. ONCE IV NEEDLE RETRACTED, IV STARTED TO BLEED THROUGH HUB. IV REMOVED AND NEW ONE PLACED. IV SENT DOWN TO QUALITY CONTROL. NO HARM REPORTED. DELAYED PLACEMENT OF EMERGENT IV THOUGH, DELAY IN CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622776 ↗MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613884 ↗MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD NEXIVA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PLACING A NEXIVA IV, THE NURSE REPORTED A MALFUNCTION THAT LED TO BLOOD LEAKING OUT OF THE HUB AFTER PLACEMENT. NO OTHER PATIENT HARM OR NURSE HARM REPORTED OTHER THAN BLOOD EXPOSURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20582166 ↗MalfunctionOct 30, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
MATERIAL #: 383539; BATCH#: 4065042. IT WAS REPORTED BY CUSTOMER THAT NEEDLE PUNCTURED THROUGH THE CATHETER DURING INSERTION. NURSE SAID THAT IT WAS DIFFICULT TO REMOVE BUT WAS ABLE TO GET THE WHOLE DEVICE AND CATHETER OUT WITHOUT ANYTHING BEING SHEARED OFF. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. NEEDLE PUNCTURED THROUGH THE CATHETER DURING INSERTION. NURSE SAID THAT IT WAS DIFFICULT TO REMOVE BUT WAS ABLE TO GET THE WHOLE DEVICE AND CATHETER OUT WITHOUT ANYTHING BEING SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569396 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
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- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
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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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