BD Insyte 381254Recalls & reported problems
Becton, Dickinson And Company · INSYTE GRAY 16GA X 1.16IN · Class 2
All models of BD Insyte (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903812547), received between Dec 12, 2017 and Jan 3, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (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.
Reports received per month
Most reported problems
Device problems
- Packaging Problem3
- Unsealed Device Packaging3
- Contamination /Decontamination Problem1
- Defective Component1
- Loss of or Failure to Bond1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE GRAY 16GA X 1.16IN CATHETER DEFECTIVE / DAMAGED CATHETER #16 WAS REQUESTED TO THE PATIENT, THE CATHETER WAS UNCOVERED AND THERE WAS EVIDENCE OF A FISSURE IN THE DISTAL MANDREL. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 12, 2024. COULD YOU PLEASE SHARE THE PHOTO SAMPLE OF THE REPORTED EVENT? THE REPORTING TEAM DID NOT PROVIDE A SAMPLE OR PHOTOGRAPHIC RECORD FOR EVALUATION. COULD YOU PLEASE SHARE THE NUMBER OF QUANTITIES AFFECTED? 1 UNIT. DATE OF THE EVENT? 01/10/2024. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? NO. FOR SAMPLE COLLECTION, PLEASE REPORT N/A. QUANTITY (B)(4). CONTAMINATED SAMPLE, IF YES PLEASE REPORT SUBSTANCE N/A.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21069441 ↗MalfunctionFeb 5, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT INSYTE GRAY 16GA X 1.16IN PACKAGE IS OPEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PACKAGING IS OPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11285830 ↗MalfunctionOct 10, 2019Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE UNIT PACKAGE IS UNSEALED AND OPENED WITH A BD INSYTE¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: PRIMARY PACKAGING IS OPENED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9175113 ↗MalfunctionDec 19, 2018Loss of or Failure to Bond; Unsealed Device Packaging
IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER PACKAGING HAD "NO ADHESION" AND OPENED EASILY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8179088 ↗MalfunctionDec 14, 2018Packaging Problem
IT WAS REPORTED THAT BD INSYTE¿ IV CANNULA ADHESIVE ON PACKAGING CAME APART ON 4 DEVICES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8165185 ↗MalfunctionNov 7, 2018Contamination /Decontamination Problem
IT WAS REPORTED BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE SEAL HAD ALREADY BEEN BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8047566 ↗MalfunctionNov 2, 2018Unsealed Device Packaging
IT WAS REPORTED THAT THE BD INSYTE¿ IV CATHETER PACKAGING WAS UNCOVERED AND THE "SEAL WAS LIFTED". THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8033916 ↗MalfunctionDec 12, 2017Unsealed Device Packaging
IT WAS REPORTED THAT WHEN THE CLINICIAN WENT TO OPEN THE PACKAGE ON A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE SEAL HAD ALREADY BEEN BROKEN.
Patient problems: No Patient Involvement
MAUDE report 7109617 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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