BD Nexiva, BD Q-Syte 383540Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 18GA 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903835409), received between Feb 12, 2018 and Jan 27, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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/Splash3
- Fluid/Blood Leak2
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Leak/Splash; Loose or Intermittent Connection
RECENTLY RECEIVED SEVERAL VIM REPORTS REGARDING THESE INFUSION NEEDLES. (SEE PHOTOS ATTACHED) THE CAPS LEAK WHEN NOT EXTRA TIGHTENED. THIS APPLIES TO BOTH THE CAP THAT COMES LOOSE AND THE CAP THAT IS ALREADY CONNECTED. WHEN WE DO NOT TIGHTEN THE CAPS, THEY EVEN FALL OFF. LEAKAGE OCCURS WITH ALL LIQUIDS WHEN THE CAPS ARE NOT ADDITIONALLY TIGHTENED. POTENTIALLY CAUSE AN EMERGENCY AND THAT IS OF COURSE NOT THE INTENTION. INCIDENTALLY, LEAKAGE OCCURS WITH ALL LIQUIDS WHEN THE CAPS ARE NOT ADDITIONALLY TIGHTENED. CYTOSTATICS IS ONLY AN EXAMPLE BECAUSE OF THE HIGHEST RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188999 ↗MalfunctionAug 15, 2024Leak/Splash; Leak/Splash
WHEN THE USER RETRIEVE THE NEEDLE, THE BLOOD GO IN THE SEPTUM NOT IN THE EXTENSION TUBING - BLOOD LEAKING FROM THE SEPTUM. BLOOD LEAKING WHEN THE USER RETRIEVE THE NEEDLE FROM THE SEPTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995658 ↗MalfunctionMar 15, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD NEXIVA DUAL PORT WITH Q-SYTE, 18G X 1.75" THE TUBING BROKE AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS RN NOTICED FLUIDS ON THE FLOOR, UPON INSPECTION NEXIVA TUBING HAD BROKE OFF OF IV, BLOOD WAS RUNNING OUT ON TO BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16545847 ↗MalfunctionSep 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BD NEXIVA¿ DUAL PORT IV CATHETER WITH Q-SYTE¿ TUBING SEPARATED FROM THE ADAPTER AFTER THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INSERTION THE TUBING DETACHED THE SECOND BLOOD RETURN. IV REMOVED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481583 ↗MalfunctionJun 6, 2018Detachment Of Device Component
IT WAS REPORTED THAT THE CATHETER OF A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM DETACHED AND WAS ABLE TO BE REMOVED WITHOUT MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7573895 ↗MalfunctionMay 30, 2018Fluid/Blood Leak
"IT WAS REPORTED DURING THE INJECTION, THAT WHILE USING THE INJECTION PUMP, THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE HAD LOSS OF CONTRAST AND SALINE SOLUTION THROUGH THE ROUTE OF MATERIAL THAT WAS FREE, EVEN USING A VALVE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. THE EVENT OCCURRED DURING THE CORONARY ANGIOGRAPHY." NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7555152 ↗MalfunctionFeb 12, 2018Fluid/Blood Leak
IT WAS REPORTED DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM AFTER INSERTION BLOOD WAS LEAKING FROM THE SELF-SEALING SEPTUM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7263509 ↗
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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.
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