BD Nexiva 383579Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 18GA X 1.25 IN DP WITH MAXZERO · Class 2
All models of BD Nexiva (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903835799), received between Apr 11, 2022 and May 12, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing2
- Leak/Splash2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT THE BLOOD FLOWED PAST THE CAP AND FREELY OUT OF THE IV LINE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? EVENT 1: 4/18/2026, 24G NEXIVA DIFFUSICS ¿ SAMPLE NOT RETAINED EVENT 2: 4/10/2026, NEXIVA 20G DUAL PORT EVENT 3: 03/13/2026, NEXIVA 18G LOT: 5310149. EVENT 4: 02/09/2026, NEXIVA 20G DUAL PORT ¿ SAMPLES RETAINED, CAN YOU PLEASE PROVIDE THE MATERIAL AND LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? EVENT 1: 24 GUAGE LEAKING AND SATURATED, EVENT 2: VENT PLUG FELL OFF DURING INSERTION AND EXPOSED THE CLINICIAN TO BLOOD. CLINICIAN STARED THIS HAS HAPPENED MULTIPLE TIMES DURING INSERTION. EVENT 3: EVENT 4: NEEDLE IS UPSIDE-DOWN AND THIS IS HOW THEY ARRIVE OUT OF THE PACKAGE. LOT#: 5310143, ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. EVENT 1: NO EVENT 2: NO, EVENT 3: NO EVENT 4: NO COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN INVESTIGATE FURTHER? EVENT 1: NO, EVENT 2: NO, EVENT 3: NO EVENT 4: 11 CASES PULLED FROM VALUE ANALYSIS. PLEASE PROVIDE 11 SHIPPING LABELS FOR ALL SAMPLES TO BE RETURNED. 814 EACH WAS THERE ANY LEAK? EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150363 ↗MalfunctionApr 26, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER EXPERIENCED TUBING CLAMP MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEFECTIVE PRODUCT WAS REMOVED FROM A NEW PACKAGE THE WHITE CLAMP WAS NOT ON THE LINE. IT IS NOT THAT THE WHITE CLAMP HAD FALLEN OFF IN ANY WAY, IT SIMPLY WAS NOT THERE TO BEGIN WITH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820400 ↗MalfunctionApr 17, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR WAS MISSING THE TUBING CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MANUFACTURED WITHOUT STANDARD WHITE CLAMP ON TUBING"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755941 ↗MalfunctionApr 11, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
IT WAS REPORTED THAT 1 BD NEXIVA CLOSED IV CATHETER HAD TUBING SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE USER REPORTED THAT AN RN STARTED AN IV FOR A PATIENT AND THE PLASTIC TUBING SEPARATED FROM THE WINGED PORTION OF THE IV HUB AND IT DETACHED AFTER PULLING BACK TO RETRACT THE NEEDLE. THE RN REPORTED THAT BLOOD STARTING POURING OUT OF THE SMALL PORT TO THE RIGHT OF THE HUB. DATE OF EVENT : (B)(6) 2022. SAMPLE AVAILABILITY : AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14073380 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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