BD Insyte Autoguard 381444Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00382903814442), received between Nov 1, 2017 and Sep 19, 2025 — classified as 7 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (38 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 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL FOLLOW UP SENT ON 24SEP2025: THE INITIAL REPORT INDICATED THAT 'BLOOD SPILLED OUT AND THE AUTO OCCLUSION FAILED.' HOWEVER, UPON REVIEW, OUR INVESTIGATION TEAM HAS CONFIRMED THAT THE REFERENCED MATERIAL# 381444 IS A NON-BLOOD CONTROL DEVICE. KINDLY CONFIRM WHETHER YOU WERE AWARE OF THIS INFORMATION. CUSTOMER RESPONSE RECEIVED ON 24SEP2025. WE WERE UNAWARE THAT THESE DO NOT HAVE A BLOOD CONTROL FEATURE. THE CLIENT EXPLAINED THAT OTHER TIME THEY HAD USED IT THE BLOOD DID NOT SPILL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101688 ↗
• MalfunctionSep 11, 2025Retraction Problem; Retraction Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025800 ↗
• MalfunctionJun 20, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT COMPLETELY RETRACT, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD INSYTE AUTOGUARD 18 GA X 1.16IN CATHETER IV DID NOT FULLY RETRACT AND TIP OF NEEDLE STILL EXPOSED WITH SAFETY DEVICE DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301286 ↗
• MalfunctionMar 3, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD CRACK IN HUB WITH BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE IV CATHETER WAS INSERTED INTO THE PATIENT IT STARTED LEAKING BLOOD AROUND THE GREEN HUB PART OF THE CATHETER. IT WAS DISCOVERED THAT THE GREEN HUB HAD A CRACK THROUGH IT. CUSTOMER RESPONSE ON (B)(6) 2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 02-17-25 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PATIENT REQUIRED A SECOND VENIPUNCTURE TO BE PERFORMED DUE TO FAILURE OF THE INITIAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509717 ↗
• MalfunctionOct 30, 2024Retraction Problem; Retraction Problem

  (B)(6) 2024. A CONTAMINATED NEEDLE STICK HAS BEEN REPORTED. WERE THERE ANY DIAGNOSTICS PERFORMED AS A RESULT OF THE CONTAMINATED NEEDLE STICK? YES. IF YES, WHAT DIAGNOSTICS WERE PERFORMED? RAPID HIV AND HEPATITIS. WAS ANY MEDICAL INTERVENTION REQUIRED? NO.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20569245 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD GN 18GA X 1.16IN LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800691 ↗
• MalfunctionJul 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD GN BLOOD SPLATTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER SUCCESSFULLY CANNULATING A PATIENTS VEIN AND RETRACTING THE NEEDLE, BLOOD SPLATTERS BACK ONTO PATIENTS AND STAFF. NO PATIENT HARM HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744096 ↗
• MalfunctionJul 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD GN BLOOD SPLATTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER SUCCESSFULLY CANNULATING A PATIENTS VEIN AND RETRACTING THE NEEDLE, BLOOD SPLATTERS BACK ONTO PATIENTS AND STAFF. NO PATIENT HARM HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744042 ↗
• MalfunctionJul 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD GN BLOOD SPLATTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER SUCCESSFULLY CANNULATING A PATIENTS VEIN AND RETRACTING THE NEEDLE, BLOOD SPLATTERS BACK ONTO PATIENTS AND STAFF. NO PATIENT HARM HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744020 ↗
• MalfunctionJul 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD GN BLOOD SPLATTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER SUCCESSFULLY CANNULATING A PATIENTS VEIN AND RETRACTING THE NEEDLE, BLOOD SPLATTERS BACK ONTO PATIENTS AND STAFF. NO PATIENT HARM HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19743594 ↗
• MalfunctionJul 12, 2024Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD SAFETY BARREL FILLED WITH BLOOD/BLOOD SPATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MECHANISM LOOKS TO HAVE FAILED CAUSING EXCESSIVE BLOOD SPATTER A UNIT SUPERVISOR IS ASKING IF THIS IS A DEFECT, ANGIOCATH CHAMBER DOESN¿T USUALLY FILL LIKE THIS, THE BLOOD SPLATTERED WHEN SHE HIT THE SAFETY BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731494 ↗
• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD BLOOD SPLATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD SPLATTERS WHEN SAFTEYING THE IV. BLOOD ON RN. PATIENT/HCP IMPACT- NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549021 ↗
• MalfunctionJun 10, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498442 ↗
• MalfunctionMar 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER HAS A HOLE THAT LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD AN ISSUE WITH THE BD INSYTE AUTOGUARD 18GA X 1.16IN CATHETER. AFTER PLACING AN IV IN THE PATIENT THE SITE WAS FOUND TO BE LEAKING AND A HOLE WAS DISCOVERED IN THE CATHETER ITSELF. WE HAVE SAVED THE CATHETER AND PACKAGING.

  Patient problems: Insufficient Information

  MAUDE report 18949963 ↗
• MalfunctionDec 6, 2023Break; Retraction Problem; Break; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279889 ↗
• InjuryAug 18, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EVENT WAS A NEEDLE STICK TO A PROVIDER WHO HAD STARTED AN IV AND THE NEEDLE DID NOT RETRACT. WHEN DISCARDING THE "SHARP" INTO THE CONTAINER, HE WAS STUCK IN THE FINGER BY THE EXPOSED NEEDLE. PRECAUTIONARY BLOOD WAS DRAWN FROM BOTH THE PROVIDER AND THE PATIENT. WE EXAMINED MULTIPLE NEEDLES FROM SAME LOT AND HAD NO OTHER ISSUES. WE CONTINUE TO USE THIS STYLE/BRAND NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17580731 ↗
• MalfunctionAug 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED 29 YO FE G3/P0 BEING PREPPED FOR C-SECTION: RN INSERTING IV CATHETER WHEN NOTED TIP SPLIT AROUND STYLUS. PATIENT REQUIRED 2ND INSERTION/PUNCTURE.

  Patient problems: Insufficient Information

  MAUDE report 17541477 ↗
• MalfunctionJul 14, 2023Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE USING THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RN WENT TO START IV AND THE NEEDLE WOULD NOT RETRACT, NEEDLE AND CATHETER WAS PULLED OUT AND THE NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE CATHETER NO HARM TO PATIENT OTHER THAN NEEDED STUCK AGAIN ADDITIONAL INFO FROM CUSTOMER: (07-JULY-2023) THE NEEDLE HAD PIERCED THE CATHETER THE KINKING HAD TO DO WITH THE NEEDLE NOT DISENGAGING AND GETTING CAUGHT ON WAY OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329683 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Retraction Problem; Material Puncture/Hole; Retraction Problem

  IT WAS REPORTED THAT DURING USE WITH BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT, NEEDLE AND CATHETER WAS PULLLED OUT OF PATIENTS ARM AND NEEDLE HAD GONE THROUGH THE CATHETER. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WENT TO START IV AND THE NEEDLE WOULD NOT RETRACT, NEEDLE AND CATHETER WAS PULLED OUT AND THE NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE CATHETER LOT 3039537 THE NEEDLE WOULD RETRACT BACK AND SO COULDN¿T USE THE IV, SO NURSE PULLED IT OUT AND THE NEEDLE WENT THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303035 ↗
• MalfunctionApr 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A COMPASS REPORT FOR A PRODUCT FAILURE OF BD INSYTE AUTOGAURD 18GA X1.16. PLEASE SEE DETAILS BELOW. BRIEF FACTUAL DESCRIPTION 18 GAUGE BD INSYTE AUTOGUARD IV VATHETER LOT 0286273 WHEN RN STARTED IV AND PUSHED THE NEEDLE RETRACTOR BUTTON, BLOOD GUSHED OUT OF IV. USUALLY THERE IS A SEAL THAT PREVENTS THE BLEEDING FROM OCCURING. THIS HAS HAPPENED WITH OTHER RNS ON THE NIGHT SHIFT PER REPORT. CS RESPONDED ON 3/30; CAN YOU CONFIRM HOW MANY OCCURRENCES OF THIS ISSUE? ARE DATES OF THE EVENTS AVAILABLE? UNSURE OF HOW MANY OCCURRENCES. THE L&D STAFF TELL ME THERE HAVE BEEN ¿SEVERAL.¿ NO DATES AVAILABLE. WAS THERE ANY PATIENT HARM OR ADVERSE OR ADVERSE EVENTS? NO. IF SO, WAS ANY MEDICAL INTERVENTION REQUIRED? WHAT WAS DONE & WHAT WAS OUTCOME? N/A IF APPLICABLE, ARE ANY PATIENT IDENTIFIERS AVAILABLE? NO. ARE ANY PHOTOS OR SAMPLES AVAILABLE? & ARE THEY CONTAMINATED? PLEASE CONFIRM ADDRESS OF FACILITY IF AVAILABLE. NO. 07APR2023 CUSTOMER RESPONSE (SEE ATTACHED EMAIL) "BASICALLY WHEN THE DEVICE RETRACTED, BLOOD LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731734 ↗
• MalfunctionApr 12, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD STRAIGHT WAS NOTICED TO BE BROKEN CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV FLUIDS WAS HOOKED UP TO CATHLON, IT WAS LEAKING. FLUIDS WERE CHANGED HOPING IT WAS FROM THE IV TUBING. IV WAS STILL LEAKING. FLUIDS REMOVED AND HOOK UP TO J-LOOP(IID) AND FLUSH, STILL LEAKING. ONCE WE WERE ABLE TO EXAMINE THE GREEN CATHLON, WE NOTICED THAT PART OF THE HUB WAS BROKEN AND IT WAS NEVER GOING TO SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727286 ↗
• MalfunctionMar 20, 2023Fluid/Blood Leak

  IV FLUIDS WAS HOOKED UP TO CATHLON, IT WAS LEAKING. FLUIDS WERE CHANGED HOPING IT WAS FROM THE IV TUBING. IV WAS STILL LEAKING. FLUIDS REMOVED AND HOOK UP TO J-LOOP(IID) AND FLUSH, STILL LEAKING. ONCE WE WERE ABLE TO EXAMINE THE GREEN CATHLON, WE NOTICED THAT PART OF THE HUB WAS BROKEN AND IT WAS NEVER GOING TO SEAL.

  Patient problems: Insufficient Information

  MAUDE report 16583301 ↗
• MalfunctionMar 9, 2023Leak/Splash; Retraction Problem; Component Missing; Leak/Splash; Retraction Problem; Component Missing

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER VENT PLUG WAS MISSING, CAUSING BLOOD TO LEAK OUT WHEN PRESSING THE BUTTON TO RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FROM THE 2 NURSES THAT WERE IN THE ROOM, ONE USING THE IV AND THE OTHER THAT WAS CHARTING THAT LOOKED AT IT AFTERWARDS. THERE IS A LITTLE FILM TYPE THING AT THE END OF THE IV ¿HANDLE¿ WHERE THE NEEDLE SUCKS INTO TO WHEN THE SAFETY BUTTON IS PRESSED. ON THAT PARTICULAR ONE, THERE WAS NO FILM PRESENT. THE BLOOD WAS THEN SHOT BACKWARDS THROUGH THE HOLE BY THE SPRING LOADING PULLING THE NEEDLE INTO IT AND ONTO THE STAFF MEMBER HOLDING IT. THEN THE BLOOD STILL INSIDE THE HANDLE DRIPPED OUT WHEN INVERTED, DUE TO THE MISSING FILM PIECE, ON TO THE PTS BED AND FLOOR AS WELL. WHAT WAS THE PATIENT OR STAFF IMPACT?: STAFF UNIFORM WAS SOILED WITH BLOOD. WHAT WAS THE PATIENT OR STAFF OUTCOME?: SCRUBS LAUNDERED BY HOSPITAL, WILL REPLACE IF UNABLE TO REMOVE BLOOD. WAS THERE ANY EXPOSURE TO BLOOD OR BODILY FLUID?: YES. WOULD YOU SAY THIS IS A RETRACTION ISSUE?: YES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513355 ↗
• MalfunctionMar 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV CATHETER LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499075 ↗
• MalfunctionJan 26, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT THERE WERE CONNECTION ISSUES AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY CONNECT THE PRIMARY TUBING TO THE IV IT¿S NOT CONNECTING PROPERLY AND LEAKING PROFUSELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251470 ↗

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-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-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-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-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-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-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-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-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-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