BD Angiocath Autoguard 381704Recalls & reported problems

Becton, Dickinson And Company · ANGIOCATH AUTOGUARD PNK 20GA X 1.88IN · Class 2

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903817047), received between Aug 6, 2018 and Aug 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Problem with Sterilization” (1 report).

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

Device problems

Problem with Sterilization1
Tear, Rip or Hole in Device Packaging1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 6, 2018Problem with Sterilization; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A BROKEN PACKAGING SEAL, THIS IS A BREACH IN THE STERILITY BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7752027 ↗

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-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-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-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-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-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-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-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-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-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-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	`00382903817047`
Brand	BD Angiocath Autoguard
Model	381704
Company	Becton, Dickinson And Company
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	K201075
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Sep 25, 2024

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
Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
1 death608 reports
BD Insyte Autoguard Shielded IV Catheter 381823
Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days
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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