BD Angiocath Autoguard 381703Recalls & reported problems

Becton, Dickinson And Company · ANGIOCATH AUTOGUARD PNK 20GA X 1.16IN · Class 2

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903817030), received between Sep 18, 2020 and Sep 21, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

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

Device Contamination with Chemical or Other Material2

Patient problems

No Consequences Or Impact To Patient2

Recent adverse event reports

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

MalfunctionSep 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT ANGIOCATH AUTOGUARD PNK 20GA X 1.16IN CATHETER WAS DISCOLORED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 381703, BATCH NO. UNKNOWN (REPORTED: 606394938). IT WAS REPORTED THAT CATHETER IS NO LONGER TRANSPARENT, MAKING IT DIFFICULT TO COMPLETE THE TREATMENT. EVENT DESCRIPTION PER EMAIL STATES: PINK PLASTIC CATHETER THAT REMAINS IN THE PT'S ARM IS NO LONGER TRANSPARENT, YOU CANNOT SEE THE BLOOD FLASH MAKING IT VERY HARD TO TELL WHETHER CATHETER IS IN THE VEIN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10561084 ↗
MalfunctionSep 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT ANGIOCATH AUTOGUARD PNK 20GA X 1.16IN CATHETER WAS DISCOLORED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381703; BATCH NO: 6063949. IT WAS REPORTED THAT THE PINK CANNULA IS OPAQUE AND MAKING UNABLE TO SEE IF IV INSERTED PROPERLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10557411 ↗

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-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-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-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-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-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-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	`00382903817030`
Brand	BD Angiocath Autoguard
Model	381703
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.

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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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