Insyte Autoguard 382933Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Winged 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
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903829330), received between Jan 19, 2023 and Feb 24, 2025 — classified as 3 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Adverse Event Without Identified Device or Use Problem2
- Leak/Splash2
- Retraction Problem2
- Fluid/Blood Leak1
- Material Split, Cut or Torn1
- Missing Information1
- Separation Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Pain3
- Air Embolism2
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2025Leak/Splash; Leak/Splash
MalfunctionFeb 24, 2025Leak/Splash; Leak/Splash
MalfunctionDec 26, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING NEEDLE WAS SLOW/DIFFICULT TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DISFUNCTIONAL RETRACTION OF THE CATHETER NEEDLE : NEED TO PRESS 2 TIMES FOR RETRACTION > RISK OF AES CAN YOU CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR THE SURVEY? YES, 1 UNIT USED (DURING OR AFTER USE) IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. WITH BLOOD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21022118 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING AIR EMBOLISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CIRCUMSTANCES OF SUR-VENUE / DESCRIPTION OF FACTS, AIR EMBOLISM. AN INCIDENT ON (B)(6) 2024 IN THE SSR POLYVALENT DEPARTMENT CLINICAL CONSEQUENCES OBSERVED, TRANSFER TO HYPERBARIC CHAMBER. AFTER THAT, I CAN'T PROVE THE IMPUTABILITY OF THE SYSTEM IN ITSELF, BUT I WANTED TO INFORM YOU. ALSO, COULD YOU MEET OUR TEAMS ABOUT THE TECHNIQUE OF HANDLING CATHETERS WITH WINGS? I WILL LET YOU GET BACK TO ME OR MY COLLEAGUE (B)(6) IN COPY OF THIS EMAIL.
Patient problems: Air Embolism
MAUDE report 20021940 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING AIR EMBOLISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CIRCUMSTANCES OF SUR-VENUE / DESCRIPTION OF FACTS AIR EMBOLISM A PERIPHERAL VENOUS LINE WAS PLACED I INCIDENT OCCURRED ON (B)(6) 2024 IN THE TRAUMA DEPARTMENT FOLLOWING A BLOCK CLINICAL CONSEQUENCES OBSERVED TRANSFER TO HYPERBARIC CHAMBER. AFTER THAT, I CAN'T PROVE THE IMPUTABILITY OF THE SYSTEM IN ITSELF, BUT I WANTED TO INFORM YOU. ALSO, COULD YOU MEET OUR TEAMS ABOUT THE TECHNIQUE OF HANDLING CATHETERS WITH WINGS? I WILL LET YOU GET BACK TO ME OR MY COLLEAGUE (B)(6) IN COPY OF THIS EMAIL.
Patient problems: Air Embolism
MAUDE report 20019564 ↗MalfunctionMar 21, 2024Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18951312 ↗MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED 20GX1" LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE SSPI INFORMED ME OF THE FOLLOWING INCIDENT WITH A CATHETER REF 382933 LOT 2340957 PER 11/30/2025. DURING INSTALLATION, THE CATHETER LEAKED AT THE BASE AFTER CONNECTION WITH THE EXTENSION. THIS IS THE FIRST TIME THIS HAS HAPPENED. WHO SHOULD I MAKE THE DECLARATION TO? THE DEVICE WAS NOT KEPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17872666 ↗InjurySep 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED 20GX1" THE CATHETER SHEARED AND FOREIGN MATTER REMAINED IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: FOREIGN BODY CEPHALIC VEIN. WHEN DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION: A FOREIGN BODY REMAINED IN THE CEPHALIC VEIN AT THE LEVEL OF THE PATIENT'S LEFT EAPULA. A FRAGMENT OF CATHETER. IT WILL BE REMOVED IN THE OPERATING ROOM. THE CATHETER WAS INSERTED INTO THE LEFT FOLD OF THE PATIENT'S ARM ON 14 AUGUST WITHOUT ANY DIFFICULTY. IT WAS REMOVED THE SAME DAY. THERE WAS SOME REDNESS, BUT THE PUNCTURE SITE WAS CLEAN. ON 28 AUGUST, THE PATIENT REPORTED PAIN IN HER ARM. WE DON'T HAVE THE BATCH NUMBER.
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 17763537 ↗MalfunctionJul 28, 2023Separation Problem; Separation Problem
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED 20GX1" THE CATHETER SLID OFF THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN UNPACKING ITS STERILE ENVELOPE, THE CATHETER THAT SHOULD COME WITH THE TROCAR GETS STUCK IN ITS PLASTIC CAP. THIS PROBLEM OCCURS RANDOMLY (ABOUT 1 IN 4 TIMES ON THE CATHETERS IN THIS BATCH 3024408) AND HAS BEEN NOTED BY DIFFERENT PEOPLE." THE DEFECTIVE PRODUCTS HAVE NOT BEEN KEPT BY THE DEPARTMENT. NO SUCH RETURNS HAVE BEEN RECEIVED FROM OTHER USER DEPARTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17417752 ↗MalfunctionJul 12, 2023Missing Information; Missing Information
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED 20GX1" THE LABELS WERE MISSING INFORMATION. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN NOTIFIED OF A SECOND ISSUE WITH THE CATHETERS FROM THE SAME VENDOR LOT. THE ISSUE WAS FOUND DURING PACK IN OUR PRODUCTION AREA. 5 CATHETER PACKS WERE OBSERVED WITHOUT ANY TEXT ON THEM AGAIN IF SAMPLES ARE REQUIRED PLEASE LET US KNOW. MATERIAL DETAILS: BD. MN: 1194416. BN: 16347320. VLOT 3024408. 56,000 DELIVERED 04APR23. 42,969 USED IN 13 FILLS. 13,031 REMAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17312946 ↗MalfunctionJan 19, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED 20GX1" THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE NEEDLE RETRACTION MECHANISM DID NOT WORK WHEN I PRESSED THE ACTIVATOR BUTTON (IT STAYED ON).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16211023 ↗
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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