Insyte Autoguard BC Pro 392537Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903925377), received between Dec 29, 2020 and Feb 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT AS THE BUTTON WAS JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VAT RN SUCCESSFULLY PLACED AN IV ON A PATIENT ON (B)(6) 2021 WITHOUT ANY ISSUES. HOWEVER, WHEN VAT RN WENT TO DISENGAGE THE NEEDLE AFTER GAINING ACCESS TO THE PATIENT'S VEIN, THE NEEDLE WAS UNABLE TO RETRACT IN THE SAFE HOUSING WHEN THE BUTTON WAS PUSHED. THE BUTTON WAS JAMMED AND UNABLE TO BE PRESSED. THE EXPOSED NEEDLE WAS CAREFULLY DISPOSED OF SAFELY IN THE SHARPS CONTAINER IN THE PATIENT'S ROOM"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11276820 ↗
• MalfunctionDec 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE IAG BC PRO PNK 20GA X 1.88IN EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 392537. BATCH NO: 9262427. IT WAS REPORTED TO ME THAT ON 11/27, IN ONE OF THE BD CATHETERS THAT WAS SEALED AND SUPPOSED TO BE STERILE IN THE PACKAGE HAS A LONG HUMAN HAIR INSIDE. THE PACKAGE WAS NOT OPENED AND THERE WAS NO BREAK IN THE SEAL BUT THE HAIR WAS INSIDE THE PACKAGING, WRAPPED AROUND THE CATHETER. CATHETER TYPE: BD INSYTE AUTOGARD BC PRO 20 GA X 1.88IN.

  Patient problems: No Patient Involvement

  MAUDE report 11092584 ↗

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-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-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-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-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-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-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-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