BD Insyte Autoguard 382547Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOG BC GRN 18GA X 1.88IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903825479), received between Dec 19, 2017 and Feb 17, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (4 reports).
11 other recalls cover devices cleared under the same FDA submission (K201075, K251654); they may or may not involve this specific model.
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
- Retraction Problem4
- Activation Problem1
- Contamination1
- Contamination /Decontamination Problem1
- Leak/Splash1
- Premature Separation1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
- Discomfort1
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Activation Problem
THE CUSTOMER IS REPORTING A RETRACTION FAILURE THREADED THE CATHETER OFF THE NEEDLE AND PRESSED THE BUTTON ON THE DEVICE TO RETRACT THE NEEDLE, BUT THE NEEDLE DID NOT RETRACT, AND THE BUTTON REMAINED STUCK IN THE DEPRESSED STATE. ADDITIONAL INFORMATION 2/11/2026: IN THE MEDSUN FORM MENTIONED THAT THE DATE OF THE EVENT AS ¿(B)(6).¿. COULD YOU PLEASE SPECIFY THE EXACT DATE WHEN THE REPORTED ISSUE HAPPENED? I DO NOT HAVE THE EXACT DATE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY TO THE PATIENT OR TEAM MEMBER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370748 ↗MalfunctionDec 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923703 ↗MalfunctionDec 8, 2025Contamination; Contamination
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744737 ↗MalfunctionJan 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PRE-OP MANAGER JUST CALLED, AND THEY ARE HAVING MORE ISSUES WITH THE INSYTE CATHETERS. PATIENTS ARE HAVING MORE INFILTRATED IV, PAIN AT THE SITE AND BRUISING. THESE ISSUES ARE OCCURRING AFTER THE IV HAS BEEN PLACED, WE DO NOT HAVE ANY PRODUCT SAVED, OR LOT# IDENTIFIED. WE HAVE ALSO HAD REPORTS FROM OUR IMAGING AND IV THERAPY DEPARTMENTS, SIMILAR TO WHAT WE HAVE BEEN SEEING WITH NEEDLES NOT COMPLETELY RETRACTING, DISENGAGED WITHOUT BUTTON BEING PUSHED, ETC. WOULD LIKE TO SEE A MEETING ON THE SCHEDULE SOONER RATHER THAN LATER. BECAUSE OF THE PATIENT ISSUES OF INFILTRATING, PAIN AND BRUISING, WE ARE NEEDING TO BRING IN AN ALTERNATE PRODUCT RIGHT AWAY.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 21179503 ↗MalfunctionNov 7, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC PARTIAL NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE NOT FULLY RETRACTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630825 ↗MalfunctionNov 7, 2024Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630701 ↗MalfunctionJul 8, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ISSUE WITH INSYTE CATHETER "WE HAVE RECEIVED FEEDBACK THAT OUR IV CATHETERS FOR OUR IV US IN THE ED ARE MALFUNCTIONING; THE SAFETY MECHANISM TO RETRACT THE NEEDLE IS NOT WORKING CORRECTLY RESULTING IN THE NEEDLE BEING UNSHEATHED AND BLOOD RUNNING OUT THE PLASTIC CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19692338 ↗MalfunctionJul 3, 2024Premature Separation; Premature Separation
MalfunctionNov 14, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 18G X 1.88IN (1.3 X 48 MM) INSYTE AUTOGUARD BC EXPERIENCED CATHETER ADAPTER/CONNECTOR/HUB CRACKED/BROKEN WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382547 BATCH NO: UNKNOWN. HOLE IN THE GREEN PART OF THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9324568 ↗MalfunctionDec 19, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGES OF A BD INSYTE¿ AUTOGUARD¿ BC WERE OPENED BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7132036 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201075, K251654. One submission often covers many models, so check the product and lot details in each record.
- Z-2007-2025 · May 21, 2025 · Open, ClassifiedREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- Z-2006-2025 · May 21, 2025 · Open, ClassifiedREF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
- Z-2004-2025 · May 21, 2025 · Open, ClassifiedREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2002-2025 · May 21, 2025 · Open, ClassifiedREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
- Z-2003-2025 · May 21, 2025 · Open, ClassifiedREF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2001-2025 · May 21, 2025 · Open, ClassifiedREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
- Z-2005-2025 · May 21, 2025 · Open, ClassifiedREF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
- Z-2000-2025 · May 21, 2025 · Open, ClassifiedREF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
- Z-1999-2025 · May 21, 2025 · Open, ClassifiedREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
- Z-2458-2024 · Jun 26, 2024 · Open, ClassifiedBD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter
- Z-0400-2024 · Oct 4, 2023 · Open, ClassifiedBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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