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BD Insyte Autoguard 382612Recalls & reported problems

Becton, Dickinson And Company · INSYTE AUTOG BC WING YEL 24GA X .75IN · Class 2

All models of BD Insyte Autoguard (33)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is a BD Insyte Autoguard winged IV catheter, a short-term plastic cannula placed into a vein. Reports mostly describe the protective needle not retracting into the catheter when the button is pressed, leaving an exposed needle in the air, plus leaking or holes in the tubing and materials found on the device. There are 46 reports, with no deaths and no injuries. No recalls name this device. Reports in the last 12 months dropped to 0, from 18 in the prior12 months.

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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00382903826124), received between Apr 26, 2018 and Aug 8, 2025 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (16 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 4 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 6 reportsApr 2025: 0 reportsMay 2025: 8 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Retraction Problem16
  • Leak/Splash12
  • Material Puncture/Hole7
  • Device Contamination with Chemical or Other Material5
  • Fluid/Blood Leak4
  • Defective Component2
  • Defective Device2
  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions34
  • No Known Impact Or Consequence To Patient6
  • Exposure to Body Fluids3
  • Insufficient Information1
  • No Information1
  • Pain1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    2 SEPTEMBER 2025 CUSTOMER ADDITIONAL INFORMATION RECEIVED: I HAD INITIALLY REPORTED BOTH MATERIALS REF # 382612 LOT # 504088 AND REF # 381412 LOT # 5058302 AND WAS LATER TOLD BY STAFF THAT NO ISSUES WERE FOUND WITH MATERIAL 382612 LOT 504088, THEY WERE PULLED AS A PRECAUTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22751553 ↗
  • MalfunctionJun 16, 2025Device Damaged Prior to Use; Defective Device; Detachment of Device or Device Component; Protective Measures Problem

    RN IN THE PROCESS OF PLACING IV. 24 G IV REMOVED FROM PACKAGING, LID AND CATHETER WAS NOT ATTACHED TO NEEDLE. WHEN IV WAS PULLED OUT OF PACKAGING, THE ENTIRE NEEDLE WAS OUT AND EXPOSED. NEEDLE PLACED IN SHARPS, NEW IV OBTAINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22210638 ↗
  • MalfunctionMay 30, 2025Retraction Problem; Material Integrity Problem; Retraction Problem; Material Integrity Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT WHEN TESTING DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:¿ NEEDLE DID NOT RETRACT PROMPTLY, AND CATHETER WOULD NOT THREAD OFF NEEDLE WHEN INSERTING PERIPHERAL IV. THERE IS A SIGNIFICANT GLITCH WHEN PRESSING THE RETRACT BUTTON. I HAD TO PULL THE NEEDLE ALL THE WAY OUT, EXPOSED, BEFORE IT WOULD RETRACT. I TESTED A COUPLE OTHERS WITH THE SAME LOT NUMBER; THEY WERE SLOW TO RETRACT.¿ KINDLY PROVIDE THE DATE OF EVENT. (B)(6) 2025 ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE TO MY KNOWLEDGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22119570 ↗
  • MalfunctionMay 30, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:¿ NEEDLE DID NOT RETRACT PROMPTLY, AND CATHETER WOULD NOT THREAD OFF NEEDLE WHEN INSERTING PERIPHERAL IV. THERE IS A SIGNIFICANT GLITCH WHEN PRESSING THE RETRACT BUTTON. I HAD TO PULL THE NEEDLE ALL THE WAY OUT, EXPOSED, BEFORE IT WOULD RETRACT. I TESTED A COUPLE OTHERS WITH THE SAME LOT NUMBER; THEY WERE SLOW TO RETRACT.¿ KINDLY PROVIDE THE DATE OF EVENT. 5/8/25 ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE TO MY KNOWLEDGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22119565 ↗
  • MalfunctionMay 8, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPRINGS ARE NOT CORRECT CAUSING A DELAY IN RETRACTING THE NEEDLE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT 21-04-2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21990868 ↗
  • MalfunctionMay 8, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPRINGS ARE NOT CORRECT CAUSING THE NEEDLE FAILING TO RETRACT WHEN THERE IS TENSION.  ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT 21-04-2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21990865 ↗
  • MalfunctionMay 7, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGAURD NEEDLE NOT RETRACTING. CUSTOMER RESPONSE ON 23-APR-2025. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THANKFULLY THERE WERE NO ADVERSE EVENTS. WE HAD 4 REPORTS OF THE NEEDLES NOT RETRACTING WHEN PRESSING THE BUTTON. THANKFULLY THE STAFF WAS ABLE TO SAFELY NAVIGATE AND DISPOSE OF THE NEEDLES WITHOUT ADVERSE EVENTS TO PATIENTS OR STAFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21980682 ↗
  • MalfunctionMay 7, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGAURD NEEDLE NOT RETRACTING. CUSTOMER RESPONSE ON 23-APR-2025. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THANKFULLY THERE WERE NO ADVERSE EVENTS. WE HAD 4 REPORTS OF THE NEEDLES NOT RETRACTING WHEN PRESSING THE BUTTON. THANKFULLY THE STAFF WAS ABLE TO SAFELY NAVIGATE AND DISPOSE OF THE NEEDLES WITHOUT ADVERSE EVENTS TO PATIENTS OR STAFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21980681 ↗
  • MalfunctionMay 7, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGAURD NEEDLE NOT RETRACTING. CUSTOMER RESPONSE ON 23-APR-2025. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THANKFULLY THERE WERE NO ADVERSE EVENTS. WE HAD 4 REPORTS OF THE NEEDLES NOT RETRACTING WHEN PRESSING THE BUTTON. THANKFULLY THE STAFF WAS ABLE TO SAFELY NAVIGATE AND DISPOSE OF THE NEEDLES WITHOUT ADVERSE EVENTS TO PATIENTS OR STAFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21980655 ↗
  • MalfunctionMay 7, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGAURD NEEDLE NOT RETRACTING. CUSTOMER RESPONSE ON 23-APR-2025. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THANKFULLY THERE WERE NO ADVERSE EVENTS. WE HAD 4 REPORTS OF THE NEEDLES NOT RETRACTING WHEN PRESSING THE BUTTON. THANKFULLY THE STAFF WAS ABLE TO SAFELY NAVIGATE AND DISPOSE OF THE NEEDLES WITHOUT ADVERSE EVENTS TO PATIENTS OR STAFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21980331 ↗
  • MalfunctionMar 25, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PROBLEM WAS NOTICE: DURING USE STERILIZATION WRAP: INCIDENT DISCOVERED DURING PATIENT CARE: NO DATE OF EVENT: 2/27/2025 12:00:00 AM INCIDENT DETAILS: WHEN THE SAFETY IS ENGAGED, IT EITHER RETRACTS IN SLOW MOTION, OR SOMETIMES GETS STUCK AND THE NEEDLE IS NOT ABLE TO RETRACT WAS PATIENT OR END-USER INJURED: NO WAS MEDICAL TREATMENT REQUIRED: NO PATIENT CURRENT STATUS: N/A. (B)(6)2025 8:29 AM 1. WERE THERE 7 PATIENTS IN TOTAL? I DON¿T HAVE AN EXACT NUMBER OF PATIENTS EFFECTED. THIS HAPPENED AT MULTIPLE SITES OVER A SPAN OF SEVERAL MONTHS BEFORE WE WERE ABLE TO IDENTIFY THE LOT NUMBER. 2. HOW MANY DIFFERENT PATIENTS WERE FOR A RETRACTION FAILURE AND HOW MANY WERE FOR A SLOW RETRACTION? I DON¿T HAVE EXACT NUMBERS. 3. DID ALL OCCURRENCES OCCUR ON (B)(6)2025? NO, THIS HAPPENED FOR SEVERAL MONTHS PRIOR TO IT BEING REPORTED. IT HAPPENED AT MULTIPLE LOCATIONS INCLUDING (B)(6). MY RESPONSES ARE THE SAME AS (B)(6). THIS WAS HAPPENING ON SEVERAL OCCASIONS OVER THE COURSE OF WEEKS TO MONTHS. I HAD 4 INCIDENTS REPORTED TO ME BEFORE THE LOT NUMBER WAS IDENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21688746 ↗
  • MalfunctionMar 25, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PROBLEM WAS NOTICE: DURING USE. STERILIZATION WRAP: INCIDENT DISCOVERED DURING PATIENT CARE: NO. DATE OF EVENT: 2/27/2025 12:00:00 AM. INCIDENT DETAILS: WHEN THE SAFETY IS ENGAGED, IT EITHER RETRACTS IN SLOW MOTION, OR SOMETIMES GETS STUCK AND THE NEEDLE IS NOT ABLE TO RETRACT. WAS PATIENT OR END-USER INJURED: NO. WAS MEDICAL TREATMENT REQUIRED: NO. PATIENT CURRENT STATUS: N/A. THU (B)(6) 2025 8:29 AM 1. WERE THERE 7 PATIENTS IN TOTAL? I DON¿T HAVE AN EXACT NUMBER OF PATIENTS EFFECTED. THIS HAPPENED AT MULTIPLE SITES OVER A SPAN OF SEVERAL MONTHS BEFORE WE WERE ABLE TO IDENTIFY THE LOT NUMBER. 2. HOW MANY DIFFERENT PATIENTS WERE FOR A RETRACTION FAILURE AND HOW MANY WERE FOR A SLOW RETRACTION? I DON¿T HAVE EXACT NUMBERS. 3. DID ALL OCCURRENCES OCCUR ON (B)(6) 2025? NO, THIS HAPPENED FOR SEVERAL MONTHS PRIOR TO IT BEING REPORTED. IT HAPPENED AT MULTIPLE LOCATIONS INCLUDING (B)(6). MY RESPONSES ARE THE SAME AS ***. THIS WAS HAPPENING ON SEVERAL OCCASIONS OVER THE COURSE OF WEEKS TO MONTHS. I HAD 4 INCIDENTS REPORTED TO ME BEFORE THE LOT NUMBER WAS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21688745 ↗
  • MalfunctionMar 21, 2025Retraction Problem; Retraction Problem

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21668131 ↗
  • MalfunctionMar 21, 2025Retraction Problem; Retraction Problem

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PROBLEM WAS NOTICE: DURING USE. STERILIZATION WRAP: INCIDENT DISCOVERED DURING PATIENT CARE: NO. DATE OF EVENT: 2/27/2025 12:00:00 AM. INCIDENT DETAILS: WHEN THE SAFETY IS ENGAGED, IT EITHER RETRACTS IN SLOW MOTION, OR SOMETIMES GETS STUCK AND THE NEEDLE IS NOT ABLE TO RETRACT. WAS PATIENT OR END-USER INJURED: NO. WAS MEDICAL TREATMENT REQUIRED: NO. PATIENT CURRENT STATUS: N/A. THU 03/20/2025 8:29 AM 1. WERE THERE 7 PATIENTS IN TOTAL? I DON¿T HAVE AN EXACT NUMBER OF PATIENTS EFFECTED. THIS HAPPENED AT MULTIPLE SITES OVER A SPAN OF SEVERAL MONTHS BEFORE WE WERE ABLE TO IDENTIFY THE LOT NUMBER. 2. HOW MANY DIFFERENT PATIENTS WERE FOR A RETRACTION FAILURE AND HOW MANY WERE FOR A SLOW RETRACTION? I DON¿T HAVE EXACT NUMBERS. 3. DID ALL OCCURRENCES OCCUR ON 02/27/2025? NO. THIS HAPPENED FOR SEVERAL MONTHS PRIOR TO IT BEING REPORTED. IT HAPPENED AT MULTIPLE LOCATIONS INCLUDING (B)(6). MY RESPONSES ARE THE SAME AS ***. THIS WAS HAPPENING ON SEVERAL OCCASIONS OVER THE COURSE OF WEEKS TO MONTHS. I HAD 4 INCIDENTS REPORTED TO ME BEFORE THE LOT NUMBER WAS ID

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21668130 ↗
  • MalfunctionMar 20, 2025Retraction Problem; Retraction Problem

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21653637 ↗
  • MalfunctionMar 20, 2025Retraction Problem; Retraction Problem

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21653546 ↗
  • MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING BLOOD LEAKED PAST THE BLOOD CONTROL FEATURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIBE THE EVENT OR PROBLEM: UPON RETRACTING THE NEEDLE FROM A 24 G IV AFTER PLACEMENT, THE BLOOD FLOWS OUT OF THE CATHETER THAT IS LEFT IN PLACE. IT ALSO HAPPENED TWICE ON A DIFFERENT DAY. THE IV HAS THE SAME LOT NUMBERS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20605928 ↗
  • MalfunctionNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING BLOOD LEAKED PAST THE BLOOD CONTROL FEATURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIBE THE EVENT OR PROBLEM: UPON RETRACTING THE NEEDLE FROM A 24 G IV AFTER PLACEMENT, THE BLOOD FLOWS OUT OF THE CATHETER THAT IS LEFT IN PLACE. IT ALSO HAPPENED TWICE ON A DIFFERENT DAY. THE IV HAS THE SAME LOT NUMBERS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20605658 ↗
  • MalfunctionMay 21, 2024Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER WITH A HOLE IN THE SIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING AN IV CATHETER ON A PATIENT. I STARTED ADVANCING THE CATHETER AND HAD NO RESISTANCE. I THEN RETRACTED THE NEEDLE. I THEN ATTACHED A J-LOOP TO THE PATIENT IV. I ATTEMPTED TO DRAW BACK BLOOD BUT ONLY GOT AIR IN THE TUBE AND A SMALL AMOUNT OF BLOOD. I THEN TRIED TO PULL THE CATHETER BACK TO SEE IF I WAS ON A VALVE, HOWEVER, I THEN NOTICED A SMALL HOLE IN THE SIDE OF THE CATHETER THAT WAS LEAKING BLOOD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19358549 ↗
  • MalfunctionMay 10, 2024Retraction Problem; Retraction Problem

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19293903 ↗
  • MalfunctionMar 26, 2024Material Puncture/Hole; Material Puncture/Hole

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18982677 ↗
  • MalfunctionMar 14, 2024Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BLOOD CONTROL VALUE MALFUNCTIONED WITH BD INSYTE AUTOG BC WING YEL 24GA X .75IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT BLOOD CONTROL VALUE OF THE IV DIDN'T WORK UPON INSERTION. BLOOD CONTROL VALUE OF THE IV DIDN'T WORK UPON INSERTION. CUSTOMER RESPONSE RECEIVED 02/20/2024 " IV STICK (PRIMARY) WAS A ¿MISS.¿ SECOND IV WAS PLACED WITHOUT INCIDENT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18906584 ↗
  • MalfunctionMar 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

    (B)(6) 2024 CUSTOMER RESPONSE ADDITIONAL INFORMATION RECEIVED: YES, HCP UNEXPECTANTLY HAD EXPOSURE TO BLOOD. YES, ON ALL OCCASIONS, HCP WERE WEARING PPE. WHEN THE NEEDLE RETRACTED, THE IV STARTED DRIPPING BLOOD DOWN THE PATIENTS ARMS AND ONTO THE GLOVED HANDS OF THE HCP. THE EXPOSURE DID REQUIRE MEDICAL INTERVENTION BY HCP TO STOP THE FLOW OF THE BLOOD FROM THE PATIENT AND IN SOME CASES, THE IV NEEDED TO BE RESTARTED. HCP DID NOT REQUIRE MEDICAL INTERVENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18887440 ↗
  • MalfunctionMar 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18852074 ↗
  • MalfunctionDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18332885 ↗

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-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-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-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-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-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-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-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-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-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

Other Catheter,intravascular,therapeutic,short-term less than 30 days devices

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Sources and updates

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