BD Insyte 381267Recalls & reported problems
Becton, Dickinson And Company · INSYTE ORN 14GA X 1.75IN · Class 2
All models of BD Insyte (10)
Data updated Oct 16, 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 00382903812677), received between Dec 18, 2017 and Feb 21, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment Of Device Component1
- Packaging Problem1
- Unsealed Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2019Packaging Problem
IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ IV CATHETER NON-WINGED MANY CATHETERS HAVE PROBLEMS WITH THE PACKAGING. THEY ARE OPEN WHILE THEY ARE STORED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8358242 ↗MalfunctionMay 3, 2018Detachment Of Device Component
IT WAS REPORTED THAT THE BD INSYTE PERIPHERAL IV CATHETER WINGED GREY PRODUCT WAS PARTLY DETACHED PRIOR TO USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7485417 ↗MalfunctionDec 18, 2017Unsealed Device Packaging
IT WAS REPORTED THAT SOME BD INSYTE¿ IV CATHETER NON-WINGED SECONDARY PACKAGES WERE FOUND OPEN OR WITH POOR SEAL INTEGRITY PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7124532 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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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