Insyte Autoguard BC Pro 392533Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903925339), received between Nov 21, 2020 and Dec 28, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2025Retraction Problem; Retraction Problem

  NEEDLE DID NOT RETRACT WHEN SAFETY ACTIVATION BUTTON WAS PUSHED. HCP NEEDLESTICK INJURY OCCURRED USING PRODUCT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23903516 ↗
• MalfunctionApr 23, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD IAG BC PRO INCOMPLETE NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY MECHANISM DID NOT WORK AS INTENDED. NEEDLE DID NOT RETRACT ALL THE WAY INTO THE HOUSING LEAVING THE CONTAMINATED SHARP EXPOSED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19169763 ↗
• MalfunctionJan 5, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD AG BC PRO NEEDLE WAS SLOW OR DIFFICULT TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MDR REFERS TO SENTENCE 2. FROM THE CUSTOMER: EARLIER THIS WEEK I STARTED A FREEHAND PERIPHERAL STICK. I HAD NOT USED THE NEW CATHETERS ON A REAL PATIENT, SO I GRABBED ONE TO PRACTICE TO REMEMBER HOW TO THREAD THE CATHETER AND RETRACT THE NEEDLED. WHEN I DID THAT (IN THE AIR) THE BUTTON WAS PUSHED IN AND LOCKED, HOWEVER THE NEEDLE DID NOT RETRACT BACK. I FIGURED IT WAS A ONE-OFF. WHEN I ACTUALLY STARTED THE IV ON THE PT, THE SAME THING HAPPENED, EXCEPT I WAS ABLE TO PUSH HARDER ON THE BUTTON AND THEN THE NEEDLE RETRACTED BACK. IT WAS ALMOST LIKE THE BUTTON GOT JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451255 ↗
• MalfunctionJan 5, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD IAG BC PRO DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MDR REFERS TO PART ONE OF THE STATEMENT. FROM THE CUSTOMER: EARLIER THIS WEEK I STARTED A FREEHAND PERIPHERAL STICK. I HAD NOT USED THE NEW CATHETERS ON A REAL PATIENT, SO I GRABBED ONE TO PRACTICE TO REMEMBER HOW TO THREAD THE CATHETER AND RETRACT THE NEEDLED. WHEN I DID THAT (IN THE AIR) THE BUTTON WAS PUSHED IN AND LOCKED, HOWEVER THE NEEDLE DID NOT RETRACT BACK. I FIGURED IT WAS A ONE-OFF. WHEN I ACTUALLY STARTED THE IV ON THE PT, THE SAME THING HAPPENED, EXCEPT I WAS ABLE TO PUSH HARDER ON THE BUTTON AND THEN THE NEEDLE RETRACTED BACK. IT WAS ALMOST LIKE THE BUTTON GOT JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450620 ↗
• MalfunctionDec 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD IAG BC PRO APPEARS TO HAVE RUST ON THE INSIDE OF THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA PHONE. ISSUE1: LOOKS LIKE IT HAS RUSTING ON THE INSIDE OF THE CATHETER. SAMPLE AVAILABLE PT IMPACT: NO. DOE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394678 ↗
• MalfunctionSep 20, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING BD¿20 G X 1-INCH INSYTE AUTOGUARD IV CATHETERS: NEEDLE MAY NOT RETRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785870 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FRAYED AT THE TIP. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE STARTED USING THE NEW IV CATHETERS FROM BD THIS WEEK. BESIDES THAT THESE IV CATHETERS ARE NOT AS SMOOTH TO INSERT & ARE TAKING THE AMBULATORY NURSES MULTIPLE ATTEMPTS TO GET AN IV STARTED SUCCESSFULLY SINCE SWITCHING TO THESE NEW CATHETERS, THIS PARTICULAR 20 G IV FROM BD WAS FRAYED AT THE TIP/BEVEL & A PART OF THE PLASTIC TIP DETACHED RIGHT BEFORE THE RN WENT TO INSERT THE TIP INTO THEIR PTS VEIN. THIS PARTICULAR IV CATHETER WAS NEVER INSERTED INTO A PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719426 ↗
• MalfunctionSep 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716761 ↗
• MalfunctionDec 3, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT 3 INSYTE AUTOGARD BD PRO CATHETERS HAD A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 DIFFERENT NURSES INSERTED THE IV THE WHITE BUTTON THAT RETRACTS THE NEEDLE DID NOT WORK. THE WHITE BUTTON WAS ALREADY PUSHED OUT. UNABLE TO THREAD THE CATHETER OFF THE NEEDLE. THE NEEDLE NEVER RETRACTED AT ALL AFTER SEVERAL ATTEMPTS. THE INCIDENT OCCURED 3 DIFFERENT TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912103 ↗
• MalfunctionNov 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IAG BC PRO PNK 20GA X 1.0IN WAS NOT WORKING WITH STABILIZATION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 392533 BATCH NO: 9248850 IT WAS REPORTED: BD INSYTE¿ AUTOGUARD¿ BC PRO AND BARD/BD STATLOCK® IV ULTRA STABILIZATION DEVICE DO NOT SEEM TO BE WORKING TOGETHER. VERBATIM: QUESTION NURSE CALLER WITH BD INSYTE¿ AUTOGUARD¿ BC PRO USING IN CONJUNCTION WITH BARD/BD STATLOCK® IV ULTRA STABILIZATION DEVICE STATES NURSES IN HER HOSPITAL ARE LOSING IV ACCESSES AND ARE FRUSTRATED THAT THE TWO PRODUCTS DO NOT SEEM TO BE WORKING TOGETHER AND THIS IS WHAT HER HOSPITAL HAS SUPPLIED THEM. MANY NURSES ARE TRYING TO PUT THE DEVICE ON AS IN THE FIRST PICTURE WHICH DOES NOT SECURE THE CATHETER AT ALL. THE SECOND PICTURE SHOWS WHAT APPEARS TO BE THE PROPER WAY TO USE IT ALTHOUGH IT'S STILL NOT ALL THAT SECURE. THE CATHETER STILL MOVES UNDER THE DEVICE AND DOES NOT APPEAR TO ACTUALLY LOCK IT IN PLACE. " RESPONSE ASKED CALLER TO EMAIL ME PICTURES OF PRODUCTS AND SHE EMAILED SIX PHOTOS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10880935 ↗

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-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-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-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-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-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-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-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-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