Insyte Autoguard BC Pro 392623Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903926237), received between Oct 27, 2020 and Jan 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 29, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269962 ↗
• MalfunctionJan 28, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258675 ↗
• MalfunctionJan 29, 2024Crack; Crack

  IT WAS REPORTED THAT A BD INSYTE AUTOG BC GRN 18GA X 1.16IN CATHETER CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENTS HAVE TO HAVE IV'S REPLACED BECAUSE THEY ARE GOING BAD. MANY OF THOSE ARE DUE TO CATHETER DAMAGE. ON MANY OF THEM THE CATHETER WILL CRACK RIGHT NEXT TO THE HUB CAUSING THEM TO LEAK UNDER THE DRESSING. PATIENTS ARE HAVING TO BE STUCK 5-6 TIMES EACH TIME THEY NEED TO REPLACE AN IV.: HELLO (B)(6), SO OVER THE PAST FEW WEEKS, I HAVE NOTICED THAT I PERSONALLY HAVE HAD A BIG INCREASE IN THE NUMBER OF IV'S THAT ARE GOING BAD ON MY SHIFT. THERE HAVE BEEN A COUPLE DAYS WHERE 3 OF MY 5 PATIENTS HAVE TO HAVE IV'S REPLACED BECAUSE THEY ARE GOING BAD. MANY OF THOSE ARE DUE TO CATHETER DAMAGE. ON MANY OF THEM THE CATHETER WILL CRACK RIGHT NEXT TO THE HUB CAUSING THEM TO LEAK UNDER THE DRESSING. IN ADDITION, I HAVE NOTICED THAT THE IV SUPPLIES THAT WE ARE USING ARE NOT GREAT. THEY ARE VERY DIFFICULT TO INSERT. I AM NOT SURE HOW TO PUT IT, BUT IT ALMOST FEELS LIKE THEY CATHETER WON'T SLIDE AGAIN THE SKIN. IT JUST STICKS TO IS LIKE IT NEEDS LUBRICATED TO SLIDE INTO THE SKIN. COMPARED TO THE MATERIALS THAT I USED AT BATHESDA NORTH, I'VE NEVER HAD SO MU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595912 ↗
• MalfunctionJan 25, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18581272 ↗
• MalfunctionMar 31, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO WINGED THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WENT TO INSERT AN IV INTO A PATIENT WHEN THE NEEDLE PUNCTURED THROUGH THE IV CATHETER TUBING MAKING THE IV CATHETER TUBING BEND AND BECOME DEFECTIVE. CATHETER IS BENT, BUT STILL INTACT. THIS IV IS A 22G LOT 22010228".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659393 ↗
• MalfunctionAug 10, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED WHILE USING THE INSYTE AUTOGUARD BC PRO WINGED IT WAS NOTICED BLOOD COMING OUT THE SIDE OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLACED A 22G INSYTE AUTOGUARD BC AND NOTICED BLOOD COMING OUT THE SIDE OF THE HUB. SHE DID NOT SAVE THE PACKAGING OF THE DEVICE BUT DID SAVE THE CATHETER AND HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198496 ↗
• MalfunctionOct 27, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO WINGED H5323-2 CATHETER WAS LOOSE AND DISLODGED DURING USE. ADDITIONALLY, THE TUBE WAS ALSO "TOO LONG". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I'M NOT SURE IF I'M DOING THIS CORRECTLY, BUT I HAVE A COMPLAINT FROM A NURSE THAT CARED FOR ME WHILE I WAS HOSPITALIZED THIS PAST WEEKEND. THE NURSE MENTIONED THE FOLLOWING WHEN SHE WAS INSERTING THE INSYTE AUTOGUARD BC PRO WINGED INTO ME: "WHEN HOLDING THE CATHETER IN PLACE FOR INSERTION, THE CATHETER IS VERY LOOSE AND FLIMSY AND DISLODGES FROM THE DEVICE EASILY." SHE ALSO MENTIONED THE TUBE IS TOO LONG".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744325 ↗

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-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-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-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-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-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-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-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-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