Insyte Autoguard 381034Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.16 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 Shielded IV catheter is a short-term intravenous line with a needle that retracts into the catheter after use. The 46 reports mostly describe the needle failing to retract, plastic pieces or loose fragments breaking off, and blood or fluid leaking or splashing; some mention small pieces of catheter left in the patient. Reports include 11 injuries and no deaths. No recalls name 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
- 46
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00382903810345), received between Aug 24, 2018 and Jul 2, 2026 — classified as 11 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (11 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 Problem11
- Break9
- Contamination6
- Leak/Splash6
- Defective Component4
- Adverse Event Without Identified Device or Use Problem3
- Fluid/Blood Leak3
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Foreign Body In Patient6
- Insufficient Information3
- Foreign Body Embolism2
- Thrombosis/Thrombus2
- Needle Stick/Puncture1
- Perforation of Vessels1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Material Puncture/Hole
IT WAS DETERMINED THAT BD INSYTE AUTOG BC GLOBAL NON FOREIGN MATTER WAS FOUND DURING INVESTIGATION. ORIGINAL REPORT: "IT WAS REPORTED THAT THE NEEDLE HAD POPPED OUT OF THE CATHETER BEFORE USE." "SALES REP MENTIONED THAT: WHEN THEY OPENED THE PACKAGE, THE NEEDLE WAS STICKING OUT OF THE CATHETER. THEY HAVE REPORTED THIS SAME ISSUE NUMEROUS TIMES IN THE PAST. NATURALLY, THEY DID NOT PERFORM THE PUNCTURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25689283 ↗MalfunctionMar 24, 2026Contamination
IT WAS REPORTED THAT WHEN CUSTOMER OPENED THE BOX TO CHECK, THERE WAS A PORTION OF THE LABEL ON THE INDIVIDUAL PACKAGES THAT HAD BLACK TAPE ON IT BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674613 ↗MalfunctionDec 17, 2025Contamination; Contamination
RN NOTED A ROUGH EDGE TO THE END OF THE CATHETER, APPEARS TO BE A LOOSE PIECE OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23834852 ↗MalfunctionDec 17, 2025Contamination; Material Integrity Problem; Contamination; Material Integrity Problem
THE ROUGH PLASTIC EDGE WAS LOOSE ON THIS ONE, CREATING A SMALL FB VISIBLE ON THE BEVEL. THIS TOOK PLACE BETWEEN NOV 10 AND NOV 28, THERE WERE A FEW INCIDENTS OF THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23834843 ↗MalfunctionDec 17, 2025Contamination; Contamination
IT WAS REPORTED THAT, ¿MULTIPLE BLACK MARKS ON THE CATHETER. THE ONLY DEVICE FOUND WITH THESE MARKS. STORED WITH THE OTHER CATHETERS UNDER THE SAME CONDITIONS.¿ NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832430 ↗MalfunctionDec 16, 2025Complete Blockage; Material Separation; Complete Blockage; Material Separation
ADDITIONAL INFORMATION: CAN YOU PLEASE RECONFIRM AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 04-11-2025.
Patient problems: Insufficient Information
MAUDE report 23816297 ↗MalfunctionJun 23, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CATHETER INSERTION, THE MANDREL CAN NO LONGER RETRACT. THIS COULD LEAD TO A BLOOD EXPOSURE ACCIDENT. SATURDAY (B)(6). COULD YOU CONFIRM THE IMPACT ON PATIENTS OF ALL THE EVENTS THAT HAVE OCCURRED? RESTING A CATHETER. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO. DID THE NEEDLE RETRACT SLOWER THAN USUAL? HAS NOT RETRACTED. DID THE NEEDLE START TO RETRACT AND THEN STOP, LEAVING THE NEEDLE EXPOSED? NO. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? YES. DID THE BUTTON GO DOWN? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310221 ↗MalfunctionJun 17, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22229303 ↗MalfunctionJun 16, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BDIAG BC PRO GLOBAL NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR SEVERAL WEEKS OR EVEN MONTHS, DURING CATHETER INSERTION, THE DURING CATHETER INSERTION, THE MANDREL CAN NO LONGER RETRACT. THIS COULD LEAD TO A BLOOD EXPOSURE ACCIDENT. 6/3/25 ¿ YOU MENTIONED SEVERAL EVENTS. COULD YOU CONFIRM THE NUMBER OF EVENTS THAT HAVE OCCURRED? PLEASE ALSO LET US KNOW THE DATE OF THE EVENTS. TUESDAY 6 MAY, MONDAY 26 MAY, SATURDAY MAY 31 ¿ COULD YOU CONFIRM THE IMPACT ON PATIENTS OF ALL THE EVENTS THAT HAVE OCCURRED? CATHETER REMOVAL ¿ WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO ¿ DID THE NEEDLE RETRACT SLOWER THAN USUAL? HAS NOT RETRACTED ¿ DID THE NEEDLE START TO RETRACT AND THEN STOP, LEAVING THE NEEDLE EXPOSED? NO ¿ DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? YES ¿ DID THE BUTTON GO DOWN? NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215518 ↗MalfunctionJun 16, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BDIAG BC PRO GLOBAL NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR SEVERAL WEEKS OR EVEN MONTHS, DURING CATHETER INSERTION, THE DURING CATHETER INSERTION, THE MANDREL CAN NO LONGER RETRACT. THIS COULD LEAD TO A BLOOD EXPOSURE ACCIDENT. ON (B)(6) 2025: YOU MENTIONED SEVERAL EVENTS. COULD YOU CONFIRM THE NUMBER OF EVENTS THAT HAVE OCCURRED? PLEASE ALSO LET US KNOW THE DATE OF THE EVENTS. TUESDAY (B)(6) 2025, MONDAY (B)(6) 2025, SATURDAY (B)(6) 2025. COULD YOU CONFIRM THE IMPACT ON PATIENTS OF ALL THE EVENTS THAT HAVE OCCURRED? CATHETER REMOVAL. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO. DID THE NEEDLE RETRACT SLOWER THAN USUAL? HAS NOT RETRACTED. DID THE NEEDLE START TO RETRACT AND THEN STOP, LEAVING THE NEEDLE EXPOSED? NO. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? YES. DID THE BUTTON GO DOWN? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215515 ↗MalfunctionJun 4, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT BD INSYTE AUTOG BC GLOBAL HUB IS CRACKED AND LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER HUB WAS CRACKED, AND BLOOD WAS LEAKING FROM THE CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140771 ↗MalfunctionJun 2, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BD INSYTE AUTOG BC GLOBAL NEEDLE PIERCING POUCH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAIN/COMMENT: NEEDLE ON CANNULA WITHIN PACKAGING DOES NOT HAVE A PLASTIC CAP. CANNULAR NEEDLE WAS FOUND STICKING OUT OF THE END OF THE PACKAGING DUE TO NO PLASTIC PROTECTIVE CAP BEING ON TOP OF THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22127004 ↗MalfunctionMay 19, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE RETRACTED PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE RETACTED BEFORE IV THROUGH PATIENTS SKIN, WHITE RETRACTOR BUTTON DEFINITELY NOT PRESSED. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045625 ↗MalfunctionMar 31, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21733926 ↗MalfunctionFeb 18, 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: NURSE STATING CANNULA WAS NOT RETRACTING WHEN BUTTON PRESSED, TRIED MULTIPLE CANNULA'S WITH THE. LOT: 4239978 FOR SAME ISSUES. TRIED NEW LOT: 4199766 SAME ISSUES WOULD NOT RETRACT. TRIED LOT: 3362802. WOULD NOT RETRACT AS WELL. TRIED LOT 4030760, WOULD ALSO NOT RETRACT RIGHT AWAY. IT APPEARS AS IF BUTTON IS GETTING STUCK. MULTIPLE STAFF TRIED WAS NOT USER ERROR. ALL CANNULA'S REMOVED FROM FLOOR AND SENT TO MATERIALS MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21403343 ↗InjuryDec 29, 2024Break; Break
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL CATHETER TIP NOT PRESENT WHEN CATHETER WAS REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE GARRISON WAS REMOVED DUE TO LIQUID SPILLAGE OF INFUSION. DURING REMOVAL IT WAS EVIDENT THAT THE DISTAL PORTION OF THE CANNULA WAS NOT PRESENT CONSEQUENCE HOSPITALIZATION (B)(6). THE DEVICE WAS IMPLANTED IN THE PATIENT; THE PATIENT SUFFERED DAMAGE AS HE UNDERWENT A CHEST CT SCAN AND CHEST X-RAY TO IDENTIFY THE RESIDUAL PIECE BELTED; IT WAS THE NURSING STAFF WHO HIGHLIGHTED THE PROBLEM DURING THE REMOVAL OF THE DEVICE; THERE WAS NO LEAKAGE OF LIQUID; MEDICAL INTERVENTION WAS NECESSARY; UNFORTUNATELY, THE DEVICE HAS BEEN DELETED AND I CAN'T SUPPLY THE LOT.
Patient problems: Foreign Body In Patient
MAUDE report 21032736 ↗MalfunctionDec 10, 2024Contamination; Contamination
IT WAS REPORTED THAT BD INSYTE AUTOG BC GLOBAL FOREIGN MATTER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT FM IN THE NEEDLE. ALTHOUGH IT HAS NOT YET BEEN OPENED, THERE ARE BLACK SPOTS ON THE INDWELLING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20896173 ↗MalfunctionDec 5, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: WHEN THE CATHETER WAS INSERTED, THE OPERATOR INJECTED AND THEN FITTED THE CATHETER. AT THIS POINT, A PIECE OF PLASTIC CAME DETACHED. UNFORTUNATELY, THE DEVICE WAS THROWN AWAY. (B)(6); HAS THERE BEEN ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS? THERE IS NO DAMAGE TO THE PATIENT, THERE IS A RUPTURE OF THE CATHETER FOR WHICH IT IS NECESSARY TO MAKE A CHANGE AND PERFORM DOUBLE PROCEDURE TO THE PATIENT. COULD YOU SHARE THE PHOTOS OF THE INCIDENT? PHOTOGRAPHIC EVIDENCE IS ADDED. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? (DETAIL) IT WAS NOT NECESSARY. WAS THERE EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PROFESSIONAL AND WHAT MEASURES WERE TAKEN. (DETAIL) THERE WAS NO EXPOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20855150 ↗MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20432997 ↗MalfunctionOct 3, 2024Material Perforation; Material Perforation
InjuryJul 26, 2024Break; Break
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TIP OF CANNULA HAS BROKEN OFF AS MO WITHDRAWING WHOLE UNIT. MO ATTEMPTING TO WITHDRAW BLOOD SAMPLE WHEN NOTICED BALLOONING AND PT COMPLAINED OF SORENESS IN LEFT CUBITAL FOSSA. WITHDREW CANNULA AND TIP SNAPPED. TORNIQUET APPLIED AND URGENT USS REQUIRED. TIP HAS BEEN SURGICALLY REMOVED - LODGED IN SUBCUTANEOUS TISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 19840381 ↗MalfunctionJul 25, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE DEPARTMENT REPORTS THAT THE CANULA CAME OUT OF ITS SHEATH DURING THE PROCEDURE. THIS RESULTED IN BLEEDING AND THEN A HEMATOMA. 9JUL. HAVE HEALTH CARE WORKERS BEEN EXPOSED TO BLOOD OR BODY FLUIDS? NO, PUT ON A PAIR OF GLOVES WERE THERE ANY PROBLEMS WITH THE SECURITY SYSTEM? (RETRACTION FAILURE, PROTECTION FAILURE, SAFETY DEVICE FAILED TO COVER THE NEEDLE PROPERLY. INDICATE IF THE DEVICE MALFUNCTIONED BEFORE OR DURING USE). ACCORDING TO THE DOCTOR: "WHEN I SAW THAT THE NEEDLE HAD PIERCED THE PLASTIC SHEATH I TOLD MYSELF THAT RETRACTING IT COULD PRODUCE BLOOD SPLASHES, I PREFERRED TO LEAVE IT AS IT WAS. THE DEVICE MALFUNCTIONED DURING USE, IT WAS IN THE PATIENT'S VEIN". HAVE OTHER MEASURES BEEN TAKEN? REMOVAL OF THE COMPRESSION DEVICE WITH A COMPRESS SET UP OF AN ALCOHOLIC THOUGHT. DISCARDED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826841 ↗MalfunctionJul 17, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19766185 ↗MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD INSYTE AUTOGUARD BC PRO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON INSERTION, THE AUTOGUARD IMMEDIATELY BEGAN BLEEDING IN THE CATHETER, TIME < 1 SEC, NOTHING ELSE ATTACHED TO CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593311 ↗MalfunctionJun 17, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOG BC BLOOD LEAKED BEYOND THE BLOOD CONTROL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT THE BLOOD CONTROL VALVE DO NOT FUNCTION PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19549618 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page