BD Insyte-W 381344Recalls & reported problems
Becton, Dickinson And Company · INSYTE-W WINGED GN 18GA X 1.16IN · Class 2
All models of BD Insyte-W (8)
Data updated Oct 18, 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 00382903813445), received between Feb 26, 2018 and Apr 20, 2022 — classified as 4 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.
Most reported problems
Device problems
- Leak/Splash3
- Device Contamination with Chemical or Other Material1
- Difficult to Remove1
- Entrapment of Device1
- Unstable1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2022Leak/Splash; Unstable; Leak/Splash; Unstable
IT WAS REPORTED THAT THE BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER LEAKED BLOOD AND BACKED OUT OF THE PATIENT'S VEIN. THIS OCCURRED 50 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "BLOOD LEAKAGE. UNFORTUNATELY, OUR CUSTOMER TOLD US THAT BLOOD ALWAYS LEAKED OUT AND THAT IT WAS NOT POSSIBLE TO FIX THE INDWELLING VEIN CANNULA PROPERLY TO THE PATIENT." "WHAT WAS THE LOCATION OF THE LEAKAGE? THE INSERTION SITE OR ELSEWHERE? ¿THERE IS ALWAYS LEAKAGE OF BLOOD FROM THE CANNULA AND IT IS NOT POSSIBLE TO FIX IT CORRECTLY ON THE PATIENT¿ DID THE NEEDLE/CATHETER BACK OUT OF VEIN? YES¿".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14162137 ↗MalfunctionMay 19, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT INSYTE-W WINGED GN 18GA X 1.16IN LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS BEING REPERFUSED ON THE DAY OF THE INCIDENT. I PUT IN THE CATHETER, PLUGGED IN MY INFUSION LINE AND WHEN I TURNED ON, I SAW A LARGE AMOUNT OF BLOOD FLOWING THROUGH THE CATHETER. THE BLOOD WAS SLIT ALONG THE LENGTH BETWEEN THE WINGS OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10069878 ↗MalfunctionAug 21, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT NEEDLE THROUGH A THE CATHETER OCCURRED BEFORE USE WITH A 18G X 1.16IN (1.3 X 30 MM) INSYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE HAS ALREADY PERFORATED THE CATHLON WHEN THE PRODUCT IS OPENED, UNUSABLE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8918217 ↗MalfunctionFeb 26, 2018Entrapment of Device; Difficult to Remove; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHILE A NURSE WAS ATTEMPTING TO REMOVE A BD INSYTE ¿ IV CATHETER WINGED, IT SEEMED TO STICK INSIDE THE VEIN MAKING IT DIFFICULT TO REMOVE. AN ANESTHETIST EXTRACTED IT FINDING ¿WHITE TRACES¿ OF GLUE ON THE CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7298152 ↗
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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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