BD Insyte-N Autoguard 381911Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903819119), received between Dec 14, 2023 and Dec 5, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Retraction Problem; Retraction Problem

  NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 23729958 ↗
• MalfunctionNov 13, 2025Material Frayed; Material Frayed

  NO NEW INFORMATION.

  Patient problems: Abrasion

  MAUDE report 23551070 ↗
• MalfunctionSep 10, 2025Material Frayed; Material Frayed

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019105 ↗
• MalfunctionOct 11, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD WINGED NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE CANULA PERFORATES THE CATHETER ON INSERTION. THIS TIME, 3 CATHETERS HAVE BEEN KEPT, AND I CAN MAKE THEM AVAILABLE TO YOU IF NECESSARY. I'M ALSO ENCLOSING A PHOTO OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427921 ↗
• MalfunctionJun 27, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD WINGED PLASTIC ON HUB PREVENTED CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024 LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT INCIDENT DETAILS: ATTEMPTED TO START PIV ON PATIENT. WRITER WHO WAS POKING FOR IV AS ABLE TO GET GOOD FLASHBACK, HOWEVER UNABLE TO SCREW FLUSH ON AS THERE WAS AN EXTRA NODULAR PIECE OF PLASTIC NOTED ON THE CATHETER. IMPACT OF INCIDENT: THIS RESULTED IN NEEDING TO POKE BABE SECOND TIME FOR PIV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627254 ↗
• MalfunctionJun 24, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD WINGED HUB THREAD IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: (B)(6) 2024. TYPE OF INCIDENT/PROBLEM: CONNECTION PROBLEM. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. INCIDENT DETAILS: PERIPHERAL IV CANNULA WAS INSERTED SUCCESSFULLY AND UPON THE INSERTER ATTEMPTING TO CONNECT THE CANNULA TO THE EXTENSION SET THE LUER WOULD NOT THREAD. VISUAL INSPECTION OF THE CANNULA SHOWS THAT ONE SECTION OF THE THREADS APPEARS TO HAVE EITHER EXTRA PLASTIC OR CRUSHED/FLATTENED ON ONE SIDE. IMPACT OF INCIDENT: BABY NEEDED AN ADDITIONAL POKE FOR PIV INSERTION DESPITE SUCCESSFUL INSERTION ON FIRST ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600467 ↗
• MalfunctionJun 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  COULD YOU PLEASE TELL DID THE CATHETER BROKE AND OR SEPARATE OR DID THE CATHETER SPLIT WHILE INSERTED POSSIBLY DUE TO THE NEEDLE PIERCING THROUGH THE CATHETER WALL. IF A PIECE OF THE CATHETER WAS SEPARATED, DID THIS REMAIN IN THE PATIENT? WAS IT RETRIEVED? "THE CATHETER WAS NOT VISUALLY SPLIT DURING THE PRE-PLACEMENT CHECK-UP. WHEN WE PRICK THE PATIENT, THE PASSAGE OF THE INITIAL SKIN IS EASY BUT AS SOON AS ABOUT 2MM IS INSERTED, A GREAT RESISTANCE IS FELT, AN INTENSE PAIN FOR THE PATIENT. IMMEDIATE REMOVAL OF THE CATHETER IS NECESSARY. WHEN IT IS REMOVED, WE NOTICE THAT THE CATHLON IS SEPARATED IN TWO AT THE END LIKE A FORK. WE DON'T THINK A PIECE CAME OFF. THIS INCONVENIENCE HAS BEEN QUITE COMMON IN RECENT WEEKS WITH THESE YELLOW CATHLONS."

  Patient problems: Pain

  MAUDE report 19574945 ↗
• MalfunctionFeb 20, 2024Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741639 ↗
• MalfunctionDec 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD WINGED NEEDLE PIERCED THROUGH THE CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: CATHETER INTACT WHEN OPENED. WHEN I WANTED TO INFUSE THE BABY, I PRICKED, BLOOD RETURNED BUT DIFFICULTY FITTING THE CATHETER. WITHDRAWAL OF THE CATHETER, THE NEEDLE HAD PIERCED THE CATHETER. DESCRIPTION OF CONSEQUENCES: INFUSION FAILURE, HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 18332404 ↗

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-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-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-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-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-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-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-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-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