Insyte Autoguard BC Pro 392633Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903926336), received between Jul 11, 2022 and Jan 16, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

11 other recalls cover devices cleared under the same FDA submission (K201075); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522680 ↗
• MalfunctionJan 13, 2024Break; Break

  IT WAS REPORTED THAT IAG BC PRO WING PNK 20GA X 1.0IN WAS LEAKING AND CRACKED AT THE HUB. IT WAS REPORTED BY CUSTOMER THAT IV WAS INSERTED SUCCESSFULLY IN PATIENT. ONCE INSERTED AND HOOKED UP TO IV FLUIDS, RN NOTICED IV WAS LEAKING UNDER DRESSING, AND THEN NOTICED IV HUB WAS BROKEN / CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509522 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL FEATURE DOES NOT WORK CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: XXX, OUR LOCAL REPRESENTATIVE HAS THE DEFECTIVE ITEMS WRAPPERS FROM THE FIRST PRODUCT COMPLAINT, WITH THE EXCEPTION OF THE NEWEST ONE FROM LATE LAST WEEK. I DO NOT HAVE A BATCH NUMBER FOR THOSE, NOR DO I HAVE A DATE THAT THEY WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857749 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE IS NOT WORKING ON THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER. THE ISSUE IS WITH THE BC VALVE/SYSTEM. AFTER INSERTION, THE BLOOD CONTROL MECHANISM/VALVE IS NOT WORKING PROPERLY AND THE INSERTION SITE BLEEDS UNTIL IT IS EITHER OCCLUDED MANUALLY OR THE PRIMED INFUSION TUBING IS CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731233 ↗
• MalfunctionMay 26, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00 EXPERIENCED SHEARING. SEVERAL HAD NOTCHES, OR KINKS IN THEM THAT WAS CAUSING SHEARING IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011517 ↗
• MalfunctionJul 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00 THERE WAS AN ISSUE OF LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ANESTHESIOLOGIST WAS PUTTING AN IV IN MY WIFE'S ARM, I HEARD HER SAY THIS THING MADE A MESS, AND IT WASN'T SUPPOSED TO DO THAT. BLOOD GOT ALL OVER AND THE DR. SAID SHE EXPECTED THE VALVE TO CLOSE. THIS HAPPENED IN THE PRE-OP ROOM, AND THERE WAS NOTHING OUT OF THE ORDINARY FROM WHAT I COULD TELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135601 ↗
• MalfunctionJul 11, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00" THE NEEDLE ONLY PARTIALLY RETRACTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE IV CATHETER FAILED. PRESSED TO RETRACT THE NEEDLE AND THE NEEDLE DID NOT RETRACT ALL THE WAY. "SAFETY MECHANISM FOR THE IV CATH BELOW FAILED " EVENT DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978532 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201075. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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