BD Insyte Autoguard 381457Recalls & reported problems

Becton, Dickinson And Company · INSYTE AUTOGUARD GRAY 16GA X 1.77IN · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903814572), received between Jun 8, 2021 and Mar 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Defective Component1
Device Contamination with Chemical or Other Material1
Leak/Splash1
Retraction Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 19, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ACCESSING PATIENT'S SINGLE LUMEN POWERFLOW PORT WITH A 16 G X 1.77 INCH INSYTE AUTOGUARD NEEDLE, THE IV NEEDLE DID NOT RETRACT WHEN PRESSING THE BUTTON LOT# 4082066.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646272 ↗
MalfunctionOct 8, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20403652 ↗
MalfunctionJun 8, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT INSYTE AUTOGUARD GRAY 16GA X 1.77IN CATHETER SEPARATED FROM THE HUB. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE CATHETER DETACHED AT THE HUB TWICE. AN APHERESIS PATIENT WAS "STUCK" 3 TIMES INSTEAD OF ONCE, THIS IS THE HARM TO THE PATIENT AS THE RESULT OF THE PRODUCT FAILURE. THE PATIENT WAS NOT CAUSED FURTHER HARM BECAUSE OF ACTIVE RECOVERY BY THE RN'S EXPERTISE. THE NURSE WAS NOT HARMED. ON (B)(6) 2021 AN APHERESIS NURSE ENTERED THE ABOVE SB SAFE(INTERNAL TRACKING SYSTEM) FOR AN ANGIOCATH (BD INSYTE AUTO GUARD LOT# 9224642 EXP 7/31/2022) THAT DETACHED AT THE HUB TWICE (TWO DIFFERENT ANGIOCATHS) DURING A POWER FLOW PORT ANGIOCATH INSERTION REQUIRED FOR AN APHERESIS TREATMENT. WE SWITCHED TO A DIFFERENT LOT# AND DID NOT HAVE ANY FURTHER ISSUES. WE HAVE THE BOX OF LOT NUMBERS IN QUESTION QUARANTINED AND ARE USING THE NEW LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11963546 ↗

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-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-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-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-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-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-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-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-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

Device details

UDI-DI	`00382903814572`
Brand	BD Insyte Autoguard
Model	381457
Company	Becton, Dickinson And Company
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	K201075, K251654
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 16, 2026

Device type (GMDN): Peripheral intravenous cannula

A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Other Catheter,intravascular,therapeutic,short-term less than 30 days devices

BD Insyte Autoguard 382523
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
660 reports
BD Insyte Autoguard 382533
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
2 recalls527 reports
BD PosiFlush 306546
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1 death608 reports
BD Insyte Autoguard Shielded IV Catheter 381823
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582 reports
BD Insyte Autoguard 381423
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
1 recall528 reports
BD Insyte Autoguard 382544
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
1 recall437 reports
BD Nexiva, BD Q-Syte 383536
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
2 recalls374 reports
BD PosiFlush 306547
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
2 recalls1 death331 reports

All Catheter,intravascular,therapeutic,short-term less than 30 days devices →

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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