BD Insyte-W 381347Recalls & reported problems
Becton, Dickinson And Company · INSYTE-W WINGED GN 18GA X 1.88IN · Class 2
All models of BD Insyte-W (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903813476), received between Feb 19, 2019 and Jul 21, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material1
- Device Markings/Labelling Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT BD INSYTE-W WINGED GN 18GA X 1.88IN HAD FOREIGN MATTER (B)(6) 2025 8:10 WHILE PERFORMING INTRAVENOUS PUNCTURE ON PATIENT IN OPERATING ROOM NO. 2, FOREIGN MATTER WAS FOUND IN THE SHEATH TUBE OF THE INTRAVENOUS CATHETER. THE CANNULA WAS IMMEDIATELY REPLACED, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22559699 ↗MalfunctionApr 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT BD INSYTE-W WINGED GN 18GA X 1.88IN HAD FOREIGN MATTER (B)(6) 2025 AFTER UNPACKING THE OUTER PACKAGING BEFORE USING A DISPOSABLE INDWELLING NEEDLE FOR INFUSION, HEALTHCARE WORKERS REMOVE THE INDWELLING NEEDLE AND FIND THAT THE TIP OF THE NEEDLE HAS A FOREIGN OBJECT AND REPLACE IT WITH ANOTHER ITEM FOR REUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901401 ↗MalfunctionNov 24, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT INSYTE-W WINGED GN 18GA X 1.88IN HAD INCORRECT LABEL INFORMATION. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO BOXES (100 NEEDLES) NEEDLES WERE GIVEN TO (B)(6) ON (B)(6) 2020. THE FEEDBACK BOXES WERE STAMPED AS FOLLOWS DURING INSPECTION. THE HOSPITAL REFUSED TO ACCEPT THEM.
Patient problems: No Patient Involvement
MAUDE report 10892436 ↗MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT "WHITE HAIRY MATTER" WAS FOUND ON THE BD INSYTE-W¿ IV CATHETER WITH WINGS BEFORE INSERTING INTO THE PATIENT. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR "LUMBOCRURAL PAIN". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, OUR HOSPITAL PATIENTS BY THE FEELING OF LUMBOCRURAL PAIN TO LIVE IN OUR HOSPITAL, PATIENTS ON (B)(6) 2020, READY TO SURGERY, THE NURSE TO INSERT THE NEEDLE, READY TO GIVE PATIENTS FOUND INDWELLING NEEDLES WITH WHITE HAIRY MATTER, FORTUNATELY, DISCOVER IN TIME, AFTER THE REPLACEMENT OF INDWELLING NEEDLE TO CONTINUE THE OPERATION."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9930892 ↗MalfunctionFeb 19, 2019Material Integrity Problem
IT WAS REPORTED THAT BD INSYTE¿ CATHETER OPENED DURING STORAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350605 ↗
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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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