BD Insyte™ Autoguard™ BC Pro 392544Recalls & reported problems
Becton, Dickinson And Company · IAG BC PRO GRN 18GA X 1.16IN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903925445), received between Jul 30, 2021 and Apr 26, 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.
Reports received per month
Most reported problems
Device problems
- Retraction Problem6
- Defective Device1
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2025Retraction Problem; Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21915525 ↗MalfunctionMar 21, 2023Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER FAILED TO RETRACT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT WOULD NOT SAFETY CORRECTLY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16587395 ↗MalfunctionDec 20, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE INSYTE AUTOGUARD BC PRO STRAIGHT, 18G X 1.16" WOULD NOT AUTORETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WOULD NOT AUTORETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018796 ↗MalfunctionDec 16, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BC PRO STRAIGHT NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED MORE OF THE AFFECTED LOT AND A COUPLE OF THE PRODUCTS WHICH HAVE BEEN UNSUCCESSFULLY SAFETIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15999778 ↗MalfunctionOct 29, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD BC PRO STRAIGHT, 18G X 1.16" THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN NEEDLE IS SAFETIED IT DOES NOT WANT TO RETRACT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15696146 ↗MalfunctionOct 29, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING INSYTE AUTOGUARD BC PRO STRAIGHT, 18G X 1.16" THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTING IV, NEEDLE DOES NOT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695943 ↗MalfunctionOct 17, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ BCS EXPERIENCED NEEDLES THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS INSERTING 18 G BD IV CATHETER, WHEN PRESSED BUTTON TO RETRACT THE NEEDLE, NEEDLE WOULDN'T RETRACT.MULTIPLE INSTANCES THAT THE NEEDLE WOULD NOT RETRACT AS DESIGNED. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS REPORTED DEFECT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15615620 ↗MalfunctionSep 21, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO SEEMS TO BE DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT SEEM TO BE DEFECTIVE. WONT RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15460440 ↗MalfunctionJul 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC PRO EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSIDE PACKAGING THERE IS A HAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15080699 ↗MalfunctionJul 30, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IAG BC PRO GRN 18GA X 1.16IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED LEAKAGE. VERBIAGE RECEIVED, I WAS CALLED TO THE PATIENT'S ROOM AND BLOOD WAS EVERY WHERE. THE PORT ON THE IV HAD FALLEN OFF AND THE IV WAS BACKFLOWING BLOOD ALL OVER HERSELF, HER BED, AND THE FLOOR. THE IV PUMP WAS TURNED OFF, PRESSURE WAS APPLIED AND THE PART WAS PLACED BACK ON THE IV WHERE IT HAD BEEN MISPLACED. THE PATIENT WAS CLEANED UP AND HER BEDDING AND GOWN WERE CHANGED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253811 ↗
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-2004-2025 · May 21, 2025 · Open, ClassifiedREF: 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-2005-2025 · May 21, 2025 · Open, ClassifiedREF: 382544 BD Insyte Autoguard 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, ClassifiedREF: 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-2007-2025 · May 21, 2025 · Open, ClassifiedREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- Z-1999-2025 · May 21, 2025 · Open, ClassifiedREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
- Z-2002-2025 · May 21, 2025 · Open, ClassifiedREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
- Z-2006-2025 · May 21, 2025 · Open, ClassifiedREF: 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, ClassifiedREF: 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, ClassifiedREF: 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, ClassifiedBD 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, ClassifiedBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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