BD Insyte-W 381357Recalls & reported problems
Becton, Dickinson And Company · INSYTE-W WINGED GRAY 16GA X 1.77IN · Class 2
All models of BD Insyte-W (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903813575), received between Jan 31, 2019 and Dec 2, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- Leak/Splash2
- Loose or Intermittent Connection1
- Unsealed Device Packaging1
Patient problems
- Blood Loss1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSYTE-W¿ IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CESAREAN SECTION, THE SECOND VEIN CHANNEL WAS ESTABLISHED ACCORDING TO THE DOCTOR'S ADVICE. AFTER SUCCESSFUL PUNCTURE, THERE WAS LEAKAGE OF BLOOD, THE NEEDLE CORE WAS PULLED OUT AND CONNECTED TO THE INFUSION SET. AFTER OBSERVATION, NO EXTRAVASATION WAS FOUND, THE PATIENT CONTINUED TO USE THE VEIN.
Patient problems: Blood Loss
MAUDE report 10933097 ↗MalfunctionNov 21, 2019Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE-W¿ IV CATHETER WITH WINGS 16GA 1.77IN (1.7 X 45 MM) EXPERIENCED A LOOSE NEEDLE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER REMOVING THE PROTECTIVE COVER OF THE NEEDLE, THE NEEDLE STARTS ROTATING INSIDE THE CATHETER AND DOES NOT STOP. A SAFE INSERTION CANNOT BE GUARANTEED. THE SAME INCIDENT WAS REPORTED FOR OTHER PRODUCTS OF THE SAME LOT, BUT THEY ARE NOT AVAILABLE. THE PROBLEM WAS DETECTED BEFORE USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9356202 ↗MalfunctionJan 31, 2019Unsealed Device Packaging
IT WAS REPORTED THAT A CATHETER'S PACKAGING FOR A BD INSYTE-W ¿ IV CATHETER OPENED DURING STORAGE.
Patient problems: No Information
MAUDE report 8294165 ↗
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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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