BD Insyte Autoguard 381523Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN · Class 2
All models of BD Insyte Autoguard (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard catheter is a short-term intravenous catheter. The 99 reports mostly describe leaks, retraction problems, and contamination or foreign matter in the fluid path, including dark spots on the inner catheter; 90 malfunctions, no deaths, 9 injuries, and a few needle sticks are mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00382903815234), received between Oct 20, 2017 and Mar 9, 2026 — classified as 9 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (32 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
- Leak/Splash32
- Retraction Problem23
- Contamination11
- Device Contamination with Chemical or Other Material11
- Contamination /Decontamination Problem8
- Material Puncture/Hole7
- Break6
- Crack5
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Known Impact Or Consequence To Patient27
- No Consequences Or Impact To Patient9
- Needle Stick/Puncture4
- No Patient Involvement3
- Foreign Body In Patient1
- Insufficient Information1
- Rupture1
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Contamination
IT WAS REPORTED THAT THERE IS FOREIGN MATTER IN/ON THE FLUID PATH. ON 05MAR2026 CUSTOMER RESPONDED STATING ADDITIONAL SAMPLES ARE TO BE ADDED. ORIGINAL COMPLAINT: REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550078 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. EVENT DATE: 2/5/2026 INJURIES OR ADVERSE EVENT: NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336581 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. EVENT DATE: (B)(6) 2026. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336109 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336103 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335628 ↗MalfunctionFeb 13, 2026Contamination
REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. EVENT DATE: (B)(6) 2026. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335599 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. EVENT DATE: 2/5/2026. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335595 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335594 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. EVENT DATE: (B)(6) 2026. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335249 ↗MalfunctionFeb 13, 2026Contamination; Contamination /Decontamination Problem
REPORTED ISSUE: PER CUSTOMER OUR NURSES OBSERVED DARK SPOTS/ROUGH SPOTS/GROOVES ON THE INNER PART OF THESE CATHETERS. EVENT DATE: (B)(6) 2026. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335128 ↗MalfunctionDec 11, 2025Retraction Problem; Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23783692 ↗MalfunctionMay 26, 2025Crack; Crack
IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS SPLIT AT THE BLUE HUB OF THE CATHETER. I HAVE FORWARDED YOUR EMAIL TO OUR SUPPLIES MANAGER. HE STATES HE HAS BEEN IN CONTACT WITH YOUR COMPANY AND IS HANDLING THE CONCERN. AS OF RIGHT NOW IT WAS A SINGLE INSTANCE AND WE HAVEN¿T HAD ANY OTHER ISSUES. ADDITIONAL INFORMATION 5/11/2025. IT WAS NOT EVIDENT UNTIL AFTER IV WAS PLACED. THIS WAS A ONE TIME OCCURRENCE AND DO FURTHER DEFECTS HAVE BEEN NOTED IN THUS LOT NUMBER AS FAR AS I AM AWARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084536 ↗MalfunctionMar 26, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PLACING A 22 G IV IN PATIENT LEFT BASILLIC NEED WAS UNABLE TO RETRACT CAUSING THE CATHETER TO REMOVE. PATIENT DID NOT EXPERIENCE PAIN DURING THE REMOVAL. NEED WAS DISCARDED AS THE NEEDLE WAS UNABLE TO RETRACT SAFELY. LOT NUMBER 4310287 BD INSYTE AUTOGAURD WINGED. WRAPPER GIVEN TO MANAGER. DESCRIBE PATIENT /(HCP) / USER IMPACT NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696661 ↗MalfunctionMar 14, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED CATHETER KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE TWO MORE DEFECTIVE 22G INSYTE CATHS. UNKNOWN DATE ¿ IN (B)(6) 2025 SOMETIME. CATH KINKED UNDER THE SKIN. HAD TO RE-STICK PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21608038 ↗MalfunctionFeb 18, 2025Crack; Leak/Splash; Crack; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21404634 ↗MalfunctionFeb 13, 2025Crack; Leak/Splash; Crack; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21380756 ↗MalfunctionJan 16, 2025Crack; Crack
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21175308 ↗MalfunctionJan 13, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED HOLES IN HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO INFORM YOU ABOUT AN ISSUE WE ENCOUNTERED WITH THE INSTYE AUTOGUARD WINGED 22GA IV CATHETER (ITEM# 381523). WE DISCOVERED SMALL HOLES IN THE HUB (BLUE PORTION) OF THREE SEPARATE IV CATHETERS. NOTABLY, EACH DEFECTIVE CATHETER BELONGED TO THE SAME LOT NUMBER, 4276445. 2 JAN 2025: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 12/18/2024. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO LASTING HARM, MULTIPLE POKES AND POSSIBLE INFECTION RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21145724 ↗MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
MATERIAL#: 381523 BATCH#: 4093016. IT WAS REPORTED BY THE CUSTOMER THAT AFTER THE IV WAS PLACED, THE EXTENSION WAS CONNECTED TO FLUSH BUT LEAKED WHERE THE EXTENSION AND IV HUB MET. I TRIED CHANGING THE EXTENSION BUT IT STILL WAS LEAKING AT THE CONNECTION THE IV NEEDED TO BE REMOVED DUE TO THE FAILURE. 2. WAS THERE ANY HARM TO THE PATIENT OR HEALTHCARE PROVIDER (HCP)? NO 3. WHAT WAS THE DATE OF THE EVENT? 10-8-24 5. WHAT MEDICATION WAS BEING ADMINISTERED AT THE TIME OF THE INCIDENT? SALINE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924911 ↗InjuryDec 1, 2024Break; Break
MalfunctionOct 10, 2024Connection Problem; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418761 ↗MalfunctionOct 10, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED DIFFICULT TO CONNECT T CONNECTOR TO HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLACED IV CATHETER BD INSYTE 22G AUTOGARD WINGED 1 IN. UNABLE TO CONNECT T-CONNECTOR EASILY, ATTEMPTED BY THIS RN AND LEXI A RN. EVENTUALLY AFTER 3 ATTEMPTS ABLE TO PLACE T-CONNECTOR BUT TOOK A PROLONGED AMOUNT OF TIME TO ATTACH. IT SOUNDS LIKE TWO OTHER NURSES HAD SIMILAR EXPERIENCES THE DAY PRIOR BUT DIDN¿T KEEP THE PACKAGE OR FILE INCIDENT. 23 SEP. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. HOW MANY EVENTS OCCURRED. ONE CONFIRMED, TOTAL OF THREE SUSPECTED BUT THERE ARE NO DETAILS FOR THE OTHER TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418748 ↗MalfunctionSep 30, 2024Contamination; Contamination
EVENT DATE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340243 ↗MalfunctionSep 29, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE PIERCED THE CATHETER RESULTING IN AN INABILITY TO RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS STARTING AN IV. THEN OBSERVED KINKING UNDER THE SKIN WHILE ADVANCING THE CATHETER. TRIED TO RETRACT NEEDLE, BUT IT WOULD NOT. IV CAREFULLY REMOVED AND IT WAS NOTED THAT NEEDLE HAD GONE THROUGH CATHETER. THE NEEDLE HAD REMAINED IN THE CATHETER THE WHOLE TIME. RN DID NOT MANIPULATE THE NEEDLE IN AND OUT OF THE CATHETER. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20330184 ↗MalfunctionSep 11, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190884 ↗
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-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-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-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-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-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-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-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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