Insyte Autoguard BC Pro 392523Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00382903925230), received between Apr 6, 2021 and Apr 2, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD IAG BC PRO NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WOULD NOT SAFETY CUSTOMER RESPONSE ON MARCH 15, 2024. 1. RN INSERTED THE DEVICE AND UPON SEEING BLOOD RETURN, ADVANCED SLIGHTLY AND PUSHED WHITE BUTTON TO RETRACT NEEDLE. DESPITE A FEW ATTEMPTS, NEEDLE DID NOT RETRACT. RN TRIED TO MANUALLY FORWARD CATHETER INTO VEIN AND COULD NOT. REMOVED DEVICE ENTIRELY AND CALLED MANAGER (MYSELF) TO LOOK. 2. NO INJURY, BUT NEEDLE EXPOSED AND PATIENT HAD TO HAVE NEW IV STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028303 ↗
• MalfunctionJan 7, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18461411 ↗
• MalfunctionDec 19, 2023Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361006 ↗
• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS BACKING OUT OF THE VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: " DURING PROCEDURES THE IV'S GO SUBCUTANEOUS/INFILTRATE." ADDITIONAL INFORMATION RECEIVED ON 22-MAY-2023. "COULD YOU PLEASE EXPLAIN IN DETAIL THE STATEMENT ¿IV GO SUBCUTANEOUS UPON INITIATION OF IV FLUID IN A VEIN THAT WAS PATENT¿ ? WHAT DOES THE IV GO SUBCUTANEOUS MEAN? - WHEN INITIATING IV ACCESS WITH THE CATHETERS IN QUESTION MULTIPLE NURSES WERE USING SAID CATHETERS AND IV'S WERE PATENT WHEN THE IV WAS INITIATED IN PRE-OP HOLDING AREA AND BEGAN AT A SLOW KEEP VEIN OPEN KVO RATE ONCE THE PATIENTS WERE TAKEN IN THE OR OR THE PROCEDURE ROOMS AND FLUIDS WERE OPEN WIDE OPEN FOR INFUSION DURING PROCEDURES THE IV'S GO SUBCUTANEOUS/INFILTRATE - THIS WAS HAPPENING ON MULTIPLE PATIENTS AND IV WERE STARTED BY MULTIPLE NURSES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131217 ↗
• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130877 ↗
• MalfunctionJun 14, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS NOT RETRACTING AFTER PLACEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "NEEDLE NOT RETRACTING WHEN IV CATHETER PLACEMENT WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130840 ↗
• MalfunctionJun 7, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "THE REPORTED PROBLEM WAS THE PLASTIC CATHETER LEFT IN THE PATIENT ARM WAS CRACKED AND STARTED LEAKING AS SOON AS THE NEEDLE WAS RETRACTED. WE HAVE PULLED THIS ENTIRE LOT OUT OF INVENTORY. PLEASE HELP WITH NEXT STEPS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080107 ↗
• MalfunctionJun 7, 2023Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS LEAKING AFTER PLACEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: "THE REPORTED PROBLEM WAS THE PLASTIC CATHETER LEFT IN THE PATIENT ARM WAS CRACKED AND STARTED LEAKING AS SOON AS THE NEEDLE WAS RETRACTED. WE HAVE PULLED THIS ENTIRE LOT OUT OF INVENTORY. PLEASE HELP WITH NEXT STEPS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080093 ↗
• MalfunctionMay 11, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER WAS DIFFICULT TO ACTIVATE, MAKING IT DIFFICULT TO REMOVE THE NEEDLE AFTER PLACING THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: OCCURRED DURING PATIENT USE BUT PER CUSTOMER, "PATIENT WASN'T INJURED THE CATHETER STICKS WHICH CAUSES ISSUES WITH IV NOT BEING PROPERLY PLACED. INJURIES OR ADVERSE EVENT: NO. CAN YOU PLEASE PROVIDE ADDITIONAL DETAILS IN REGARDS TO THE ISSUE? IT ALMOST FELT LIKE THE NEEDLES WERE BLUNT AND THEY WERE "TOUGH" TO ADVANCE CATHETERS ONCE INSERTED. WAS THE TIP ADHESION ¿BROKEN¿ PROPERLY? YES. WAS THERE AN ISSUE WITH THE RETRACTION? YES IT WAS HARD TO PUSH THE BUTTON ON SOME OF THEM. WAS THERE ANY PATIENT IMPACT OR PATIENT INVOLVEMENT? YES, CAUSED MULTIPLE IV STICKS ON PATIENTS BECAUSE CATHETERS WOULD NOT ADVANCE OR THEY WERE SO HARD TO ADVANCE CAUSED TO BLOW THE VEIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912787 ↗
• MalfunctionMar 21, 2023Activation Problem; Activation Problem

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO STRAIGHT, 22G X 1.00" THE NEEDLE WOULD NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO DO AUTOMATIC RETRACTABLE SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586815 ↗
• MalfunctionDec 13, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE 3 BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING 392523 HAD A MISFIRE WITH THE SAFETY DEVICE THAT RETRACTS THE NEEDLE IN THE IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971528 ↗
• MalfunctionDec 3, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT 2-3 BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETERS EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WHITE BUTTON WAS ALREADY PUSHED OUT. UNABLE TO THREAD THE CATHETER OFF THE NEEDLE. THE NEEDLE NEVER RETRACTED AT ALL AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912104 ↗
• MalfunctionAug 18, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER WAS SHEARED WITH A BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "IT WAS REPORTED THAT THE CATHETER SHEARED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254828 ↗
• MalfunctionAug 10, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER LEAKED FLUID AT THE HUB CONNECTION DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON 7/26 A 22G 1 INCH BD INSTYLE AUTOGAURD BC PRO WAS PLACED ON OUR PATIENT IN THE LEFT FOREARM. IV INSERTED, FLASH NOTED AND CATHETER THREADED WITHOUT COMPLICATION, NEEDLE RETRACTED WITH SAFETY BUTTON. SOME BLOOD NOTED AT INSERTION SITE BUT DID NOT RETURN AFTER CLEANED UP. IV FLUSHED WITHOUT COMPLICATION NO LEAKING NOTED AT THIS POINT. SECURED WITH TAGEDERM AND TAPE. FLUIDS RUNNING SLOW TKO. AFTER ABOUT 10 MINUTES PATIENT CALLED STAFF IN AND LEAKING NOTED WHEN WE ATTEMPTED TO SEE IF HUB NEEDED TO BE SECURED THAT IS WHEN IT WAS NOTICED FLUID WAS LEAKING WAS WHERE HUB MEETS CATHETER. FLUIDS STOPPED IMMEDIATELY AND CONCERN WAS THAT CATHETER WOULD DISLODGE FROM HUB, WE SLOWLY REMOVED IV CATHETER WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15205702 ↗
• MalfunctionJun 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE BROKE WHILE USING THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER EXPRESSED THAT ONE OF OUR CATHETER NEEDLES SHOT OUT INTO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14721095 ↗
• MalfunctionMay 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER HAD THE NEEDLE PIERCE THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE OF THE PERIPHERAL INTRAVENOUS LINE (PIV) PUNCTURED THE CATHETER WHEN INSERTING INTO CHILD'S VEIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291869 ↗
• MalfunctionJun 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IAG BC PRO BLU 22GA X 1.0IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED LEAKAGE AND HOLE IN CATHETER (CATHETER DEFECTIVE/ DAMAGED). VERBATIM: THE IV WAS INSERTED INTO THE PATIENT. THE NURSE REPORTING THE EVENT STATED BLOOD WAS SEEN DRIPPING THROUGH THE PROXIMAL END OF THE CATHETER AS SOON AS THE FLASH ENTERED THE CATHETER. SHE INITIALLY THOUGHT THIS WAS BLOOD FROM THE PATIENT PUNCTURE SITE. THE CATHETER WAS ADVANCED AND THE BUTTON DEPRESSED TO REMOVE THE NEEDLE. SHE ATTACHED THE J-LOOP AND FLUSHED THE CATHETER WHICH IMMEDIATELY LEAKED. THE IV WAS REMOVED AND THE PATIENT NEEDED TO SUSTAIN AN ADDITIONAL IV INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918090 ↗
• MalfunctionJun 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IAG BC PRO BLU 22GA X 1.0IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED LEAKAGE AND HOLE IN CATHETER (CATHETER DEFECTIVE/ DAMAGED). VERBATIM: THE IV WAS INSERTED INTO THE PATIENT. THE NURSE REPORTING THE EVENT STATED BLOOD WAS SEEN DRIPPING THROUGH THE PROXIMAL END OF THE CATHETER AS SOON AS THE FLASH ENTERED THE CATHETER. SHE INITIALLY THOUGHT THIS WAS BLOOD FROM THE PATIENT PUNCTURE SITE. THE CATHETER WAS ADVANCED AND THE BUTTON DEPRESSED TO REMOVE THE NEEDLE. SHE ATTACHED THE J-LOOP AND FLUSHED THE CATHETER WHICH IMMEDIATELY LEAKED. THE IV WAS REMOVED AND THE PATIENT NEEDED TO SUSTAIN AN ADDITIONAL IV INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918089 ↗
• MalfunctionJun 1, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT IAG BC PRO BLU 22GA X 1.0IN CATHETER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED LEAKAGE AND HOLE IN CATHETER (CATHETER DEFECTIVE/ DAMAGED). VERBATIM: THE IV WAS INSERTED INTO THE PATIENT. THE NURSE REPORTING THE EVENT STATED BLOOD WAS SEEN DRIPPING THROUGH THE PROXIMAL END OF THE CATHETER AS SOON AS THE FLASH ENTERED THE CATHETER. SHE INITIALLY THOUGHT THIS WAS BLOOD FROM THE PATIENT PUNCTURE SITE. THE CATHETER WAS ADVANCED AND THE BUTTON DEPRESSED TO REMOVE THE NEEDLE. SHE ATTACHED THE J-LOOP AND FLUSHED THE CATHETER WHICH IMMEDIATELY LEAKED. THE IV WAS REMOVED AND THE PATIENT NEEDED TO SUSTAIN AN ADDITIONAL IV INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918086 ↗
• MalfunctionMay 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IAG BC PRO BLU 22GA X 1.0IN NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:(B)(4). IT WAS REPORTED THAT THE NEEDLE BROKE OFF THROUGH THE SIDE OF THE SHEATH. VERBATIM: THE NURSE WAS STARTING AN IV ON A PATIENT AND BLOOD BEGAN TO COME OUT OF THE SITE SO SHE PULLED OUT THE NEEDLE. SHE COULD SEE THAT THE NEEDLE HAD BROKEN OFF THROUGH THE SIDE OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772770 ↗
• MalfunctionApr 9, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT IAG BC PRO BLU 22GA X 1.0IN CATHETER BROKE AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 392523 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE PIV CATH BROKE AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646150 ↗
• MalfunctionApr 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER LEAKED BLOOD AFTER PLACEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN USING A 22G BLOOD CONTROL INSYTE AUTOGUARD THAT BLOOD IS STILL COMING OUT AFTER PLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625339 ↗

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-2001-2025 · May 21, 2025 · Open, Classified
  REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
• Z-2002-2025 · May 21, 2025 · Open, Classified
  REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
• Z-2004-2025 · May 21, 2025 · Open, Classified
  REF: 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-2000-2025 · May 21, 2025 · Open, Classified
  REF: 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-2003-2025 · May 21, 2025 · Open, Classified
  REF: 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-2005-2025 · May 21, 2025 · Open, Classified
  REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
• Z-2007-2025 · May 21, 2025 · Open, Classified
  REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
• Z-1999-2025 · May 21, 2025 · Open, Classified
  REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
• Z-2006-2025 · May 21, 2025 · Open, Classified
  REF: 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-2458-2024 · Jun 26, 2024 · Open, Classified
  BD 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, Classified
  BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533