Insyte Autoguard 381033Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.00 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard BC Pro intravenous catheter is a short-term IV line with a retractable needle and blood control feature. Most of the 27 reports describe the needle failing to retract after the catheter was placed, along with contamination on the catheter tip, leaking, and packaging problems. Three reports describe injuries, including one where a piece broke off and stayed inside a patient and had to be removed in surgery. No deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903810338), received between Aug 23, 2018 and Jun 18, 2026 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (10 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
- Retraction Problem10
- Contamination3
- Device Contamination with Chemical or Other Material3
- Fluid/Blood Leak2
- Leak/Splash2
- Packaging Problem2
- Activation Failure1
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Known Impact Or Consequence To Patient6
- Insufficient Information3
- Bacteremia1
- Foreign Body In Patient1
- Needle Stick/Puncture1
- Vasculitis1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2026Break
I WOULD LIKE TO REPORT AN PRODUCT INCIDENT WITH BD INSYTE AUTOGUARD CANNULA 20G (PINK) ON (B)(6) 2026 INVOLVING THE CANULA LINE BREAKING APART AND PART BEING LEFT INSIDE A PATIENT AT (B)(6) HOSPITAL. THE PATIENT HAD TO GO TO THEATRE TO HAVE THE PART REMAINING INSIDE THEM REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 25550007 ↗MalfunctionMay 6, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25095143 ↗MalfunctionMar 30, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. WHEN THE METAL GUIDE WIRE WAS WITHDRAWN AFTER THE CATHETER WAS INSERTED, IT DID NOT REMAIN IN THE CHAMBER. IT WAS REPORTED THAT WHEN THE METAL GUIDE WIRE WAS RELEASED AFTER THE CATHETER WAS INSERTED, IT DID NOT RETRACT INTO THE CHAMBER, MEANING IT HAD TO BE REMOVED COMPLETELY FROM THE CANNULA, WITH A RISK OF ACCIDENTAL PUNCTURE WHEN DID THE INCIDENT OCCUR? DURING USE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24723942 ↗MalfunctionMar 30, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24722896 ↗InjuryJul 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
MalfunctionMay 5, 2025Contamination; Contamination
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL FOREIGN MATTER ON CATHETER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF OCCURRENCE: (B)(6) 2025 DESCRIPTION: WHEN UNBLOCKING THE CATHETER, THERE WAS A PLASTIC JOINT (PROBABLY FROM THE CAP) ON THE TIP. CONSEQUENCES: DELAY IN MANAGEMENT. IMMEDIATE ACTION TAKEN: DISCARD THE DEVICE. CHANGE CATHETER WITH SAME REFERENCE BUT DIFFERENT BATCH (=INTACT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21963766 ↗MalfunctionMay 2, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952125 ↗MalfunctionMar 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL BLOOD CONTROL FEATURE DID NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHC COMPLAINT REFERENCE #: (B)(4). (B)(6). CAT# OF PRODUCT BEING COMPLAINED: BD381033. DESCRIPTION OF PRODUCT: CATHETER INS AG 20GX1.00 IN 50 EA/BX 4 BX/CA (200). LOT OR S/N: (B)(6) COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO. INCIDENT DATE: (B)(6) 2025. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): "NEW ANGIOCATHS, WE STARTED USING IN (B)(6), ARE SUPPOSED TO HAVE A STOP BACK FLOW F BLOOD FEATURE (BACKCHECK VALVE IN THEM), THIS HAS BEEN SPERATICALLY NOT WORKING SINCE WE STARTED USING THEM. WE WROTE DOWN 4 INSTANCES, BUT IT HAS BEEN SEVERAL. ESPECIALLY THE 20GA IV'S, BUT WE USE THAT SIZE MORE." "WE HAVE NOTICED THE ONES THAT DO NOT HOLD THE FLOW OF BLOOD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21637035 ↗MalfunctionFeb 21, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21439964 ↗MalfunctionJan 29, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOG BC GLOBAL NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT NEEDLE RETRACTION FAILURE. WHEN CUSTOMER PRESSED THE BUTTON TO RETRACT THE PUNCTURE NEEDLE, IT DID NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21270020 ↗MalfunctionNov 27, 2024Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20790416 ↗MalfunctionOct 27, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL CATHETER TIP IS JAGGED/ROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER DESCRIBED EVENT: WHEN THE CANNULA IS INSERTED INTO THE VEIN, THEY SEE THE FLUSH BUT THEN GETS STUCK AND CANNOT BE FURTHER ADVANCED. THE TIP OF THE CATHETER IS NOT SMOOTH -IT IS JAGGED/ROUGH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540988 ↗MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20162432 ↗MalfunctionJul 22, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801737 ↗MalfunctionMar 11, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT WHILE USING THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT NEEDLE RETRACTION FAILURE. CUSTOMER REPORTED THAT NEEDLE DOES NOT RETRACT WHEN BUTTON IS PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882708 ↗MalfunctionFeb 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717024 ↗MalfunctionJan 26, 2024Contamination; Contamination
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL PNK 20GA X 1.0IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE COMPLAINT STATES THAT SHE ONCE AGAIN HAS A CATHETER WITH WHAT APPEARS TO BE A SORT OF PLASTIC BLADE ON THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18591738 ↗MalfunctionJan 11, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT WHILE USING TWO BD INSYTE AUTOGUARD BC SHIELDED IV CATHETERS THE NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT NEEDLE RETRACTION FAILURE. CUSTOMER REPORTED THAT NEEDLE DOES NOT RETRACT WHEN BUTTON IS PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18498432 ↗MalfunctionOct 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003378 ↗MalfunctionSep 28, 2023Retraction Problem; Activation Failure; Retraction Problem; Activation Failure
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD AN IV NOT AUTO RETRACT UPON PUSHING THE BUTTON. I HAD TO TAKE THE NEEDLE OUT OF THE PATIENT AND REATTEMPT THE IV START AS I COULD NOT GET THE CANNULA AWAY FROM THE NEEDLE POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839441 ↗MalfunctionApr 22, 2019Material Deformation
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS BURRED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER WAS BURR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8537206 ↗MalfunctionMar 15, 2019Contamination /Decontamination Problem; Packaging Problem
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A STERILITY BREACH WITH THE PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "THE INTEGRITY OF STERILE PACKAGING OF CATHETERS IS NOT CONFORM. THE PACKAGES ARE ALL OPEN ON THE TOP."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8425629 ↗MalfunctionDec 26, 2018Packaging Problem
IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD AN INK LIKE STAIN ON THE PACKAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8196478 ↗MalfunctionDec 14, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A BLACK SMEAR ON THE NEEDLE TIP OR CATHETER TIP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8166314 ↗MalfunctionOct 31, 2018Structural Problem
IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAD A BURR ON THE CATHETER TIP. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8025237 ↗
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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