BD Insyte Autoguard Shielded IV Catheter 381823Recalls & reported problems
Becton, Dickinson And Company · INSYTE AUTOGUARD BL 22GA X 1.0IN · Class 2
All models of BD Insyte Autoguard Shielded IV Catheter (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard is a shielded intravenous catheter. Of the 595 reports naming it, many describe the needle retracting early, sometimes splashing blood onto staff, and some describe contamination or parts breaking. The reports include 24 injuries and no deaths. 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
- 582
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 582 adverse event reports that list this exact device (DI 00382903818235), received between Oct 23, 2017 and Sep 23, 2026 — classified as 24 injuries, 558 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (164 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 Problem164
- Leak/Splash126
- Device Contamination with Chemical or Other Material69
- Break41
- Material Protrusion/Extrusion20
- Defective Component17
- Material Puncture/Hole16
- Packaging Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions303
- No Known Impact Or Consequence To Patient147
- No Consequences Or Impact To Patient61
- Insufficient Information21
- No Patient Involvement18
- Needle Stick/Puncture15
- Pain11
- Foreign Body In Patient8
Recent adverse event reports
The 25 most recent of 582 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle did not retract.Event Details: The safety device is not functioning properly retracting returning.The technical complaint posed a risk to the Patient? No
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870781 ↗MalfunctionSep 23, 2026Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle did not retract.Event Details: The safety device is not functioning properly retracting returning.The technical complaint posed a risk to the Patient? No
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870780 ↗MalfunctionSep 23, 2026Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle did not retract.Event Details: The safety device is not functioning properly retracting returning.The technical complaint posed a risk to the Patient? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870776 ↗MalfunctionSep 23, 2026Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle did not retract.Event Details: The safety device is not functioning properly retracting returning.The technical complaint posed a risk to the Patient? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870737 ↗InjuryAug 5, 2026Leak/Splash; Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle prematurely retracted and blood splattered.It was reported that while securing the canula of a 22G catheter, the canula retracted, causing blood to splash onto my glove, lab coat, and pants. This incident had already occurred the previous week.The 2nd time, blood splattered on the nurse's scrubs and in her eye.The nurse followed the facility's AES protocol.I have not received any further reports of long-term effects or serious injuries.I don't know the exact dates.
Patient problems: Eye Injury
MAUDE report 50141137 ↗MalfunctionAug 4, 2026Leak/Splash; Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle prematurely retracted and blood splattered.It was reported that while securing the canula of a 22G catheter, the canula retracted, causing blood to splash onto my glove, lab coat, and pants. This incident had already occurred the previous week.The first time, blood splattered on the nurse's scrubs.I don't know the exact dates.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130649 ↗MalfunctionJun 16, 2026Premature Activation; Retraction Problem
IT WAS REPORTED THAT THE NEEDLE RETRACTS ON ITS OWN, LEAVING ONLY THE PLASTIC CATHETER, WHICH MAKES IT IMPOSSIBLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526685 ↗MalfunctionMay 12, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE BATCH IN QUESTION HAS A FAILURE IN THE SAFETY DEVICE DURING ACTIVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153517 ↗MalfunctionMay 6, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE PARTIALLY RETRACTED. A DATE RANGE IS PROVIDED, THEREFORE THE EVENT DATE IS NOT KNOWN. WHAT DEVIATION DID YOU FIND WITH THE MATERIAL? THE PRODUCT IS TRIGGERING BEFORE IT IS USED. WHAT PART/COMPONENT/PART OF THE PRODUCT IS INVOLVED IN THE COMPLAINT? THE SAFETY VALVE WAS ALREADY TRIGGERED AND THE NEEDLE WAS ALREADY RETRACTED INTO THE DISPOSAL PRODUCT. PURPOSE OF USE: IN WHICH PROCEDURE WAS THE MATERIAL BEING OR WOULD IT BE USED? WHEN PUNCTURING THE PATIENT, IT WAS FOUND THAT THE SAFETY VALVE HAD ALREADY BEEN ACTIVATED. IN WHICH SITUATION WAS THE DEVIATION IDENTIFIED? DURING USE ON THE PATIENT/CONTACT WITH THE PATIENT. WAS THERE ANY DAMAGE TO THE HEALTH OF THE PATIENT OR THE PROFESSIONAL WHO HANDLED THE MATERIAL? NO WAS MEDICAL INTERVENTION NECESSARY? NO WAS SURGICAL INTERVENTION NECESSARY? NO WAS THERE A NEED FOR HOSPITALIZATION OR PROLONGED HOSPITALIZATION? NO WAS THERE ANY EXPOSURE TO CHEMICAL/BIOLOGICAL AGENTS (REGARDLESS OF THE USE OF PPE)? NO WAS THERE AN ACCIDENTAL NEEDLE PUNCTURE? NO DID THE EVENT LEAD TO DEATH? NO WAS ANVISA NOTIFIED? INFORM NUMBER. NO WAS A SECOND MATERIAL AND/OR INCIDENT NOTIFIED? NO ADDITIONAL INFORMATION RECEIVED ON 24-APR-2
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092342 ↗MalfunctionMay 5, 2026Retraction Problem; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. A DATE RANGE IS PROVIDED, THEREFORE THE EVENT DATE IS NOT KNOWN. WHAT DEVIATION DID YOU FIND WITH THE MATERIAL? THE PRODUCT IS TRIGGERING BEFORE IT IS USED. WHAT PART/COMPONENT/PART OF THE PRODUCT IS INVOLVED IN THE COMPLAINT? THE SAFETY VALVE WAS ALREADY TRIGGERED AND THE NEEDLE WAS ALREADY RETRACTED INTO THE DISPOSAL PRODUCT. PURPOSE OF USE: IN WHICH PROCEDURE WAS THE MATERIAL BEING OR WOULD IT BE USED? WHEN PUNCTURING THE PATIENT, IT WAS FOUND THAT THE SAFETY VALVE HAD ALREADY BEEN ACTIVATED. IN WHICH SITUATION WAS THE DEVIATION IDENTIFIED? DURING USE ON THE PATIENT/CONTACT WITH THE PATIENT. WAS THERE ANY DAMAGE TO THE HEALTH OF THE PATIENT OR THE PROFESSIONAL WHO HANDLED THE MATERIAL? NO. WAS MEDICAL INTERVENTION NECESSARY? NO. WAS SURGICAL INTERVENTION NECESSARY? NO. WAS THERE A NEED FOR HOSPITALIZATION OR PROLONGED HOSPITALIZATION? NO. WAS THERE ANY EXPOSURE TO CHEMICAL/BIOLOGICAL AGENTS (REGARDLESS OF THE USE OF PPE)? NO. WAS THERE AN ACCIDENTAL NEEDLE PUNCTURE? NO. DID THE EVENT LEAD TO DEATH? NO. WAS ANVISA NOTIFIED? INFORM NUMBER. NO. WAS A SECOND MATERIAL AND/OR INCIDENT NOTIFIED? NO. ADDITIONAL INFORMATION RECEIVED O
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083231 ↗MalfunctionMay 4, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE PREMATURELY RETRACTED. "IT WAS REPORTED THAT WHEN TAKEN OUT OF THE PACKAGING, THE DEVICE WAS ALREADY ACTIVATED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070883 ↗MalfunctionMar 25, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. "RESISTANCE WHEN INSERTING CATHETER AND BREAKAGE DURING PUNCTURE". ADDITIONAL INFORMATION RECEIVED ON 16 MAR 2026: WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. YES, BECAUSE PATIENTS HAD TO BE PUNCTURED MORE THAN ONCE WHEN THERE WAS A PROBLEM WITH THE CATHETER. COULD YOU CONFIRM THE DATE ON WHICH THE EVENT OCCURRED? THERE WERE SEVERAL EPISODES, I DON'T HAVE A SPECIFIC DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689485 ↗MalfunctionMar 20, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. WHEN SALINIZING A VENOUS ACCESS, IT WAS NOTICED THAT THE VALVED CONNECTOR WAS EXTERNALIZED. ADDITIONAL INFORMATION RECEIVED ON 03-MAR-2026 EMAIL FOLLOW UP: COULD YOU PLEASE CONFIRM HOW MANY UNITS OF THE PRODUCT PRESENTED THE ISSUE/DEFECT? THREE CATHETERS SHOWED THE DEVIATION. WHEN WAS THE ISSUE/DEFECT IDENTIFIED: BEFORE, DURING, OR AFTER USE? THE DEFECT WAS ONLY OBSERVED AFTER THE PUNCTURE, AS THE COMPLAINT ALSO REFERRED TO THE NEEDLE NOT BEING RETRACTED. WAS THERE ANY HARM TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. WE RECEIVED NO INFORMATION ABOUT DAMAGE, BUT IT IS A RISKY CIRCUMSTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648003 ↗MalfunctionMar 19, 2026Retraction Problem
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643307 ↗MalfunctionMar 11, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570958 ↗MalfunctionMar 11, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568417 ↗MalfunctionMar 6, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24535771 ↗MalfunctionMar 3, 2026Retraction Problem
IT IS REPORTED THAT THE NEEDLE DOES NOT RETRACT. "AFTER PERFORMING THE PUNCTURE, THE JELCO DID NOT COLLECT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494892 ↗MalfunctionMar 2, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491515 ↗MalfunctionMar 2, 2026Retraction Problem; Material Protrusion/Extrusion; No Flow
IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER RESULTING IN AN INABILITY TO RETRACT. BEFORE INSERTING THE NEEDLE, THE NURSE CHECKED THE CATHETER BY PULLING THE NEEDLE OUT SLIGHTLY. THE CATHETER APPEARED NORMAL. ONCE THE NEEDLE WAS IN THE PATIENT'S VEIN, A SLIGHT SWELLING APPEARED UNDER THE PATIENT'S SKIN. NO BLOOD RETURN. THE NURSE PULLED THE CATHETER OUT AGAIN. THE CATHETER HAD BEEN PIERCED BY THE NEEDLE AND THE NEEDLE WOULD NOT RETRACT. NO ADVERSE EVENTS AFFECTING THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION 2/26/2026: THE EVENT TOOK PLACE ON (B)(6) 2026. THERE WERE NO CONSEQUENCES IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484838 ↗MalfunctionMar 2, 2026Nonstandard Device
IT WAS REPORTED THAT THE CATHETER IS DAMAGED. WHEN PERFORMING VENOUS ACCESS PUNCTURE, RESISTANCE WAS NOTICED IN THE PROGRESSION OF THE CATHETER. THE PROCEDURE WAS INTERRUPTED AND THE CATHETER REMOVED, REVEALING DAMAGE TO THE PLASTIC PORTION OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482974 ↗MalfunctionFeb 27, 2026Retraction Problem
IT WAS REPORTED THAT THE MANDREL COLLECTION DEVICE DID NOT WORK, CAUSING A PUNCTURE ACCIDENT. ON THE SAME DAY, ANOTHER EMPLOYEE IDENTIFIED A SECOND UNIT WITH THE SAME PROBLEM.
Patient problems: Insufficient Information
MAUDE report 24475630 ↗MalfunctionFeb 27, 2026Retraction Problem
IT WAS REPORTED THAT THE MANDREL COLLECTION DEVICE DID NOT WORK, CAUSING A PUNCTURE ACCIDENT.
Patient problems: Needle Stick/Puncture
MAUDE report 24475624 ↗MalfunctionFeb 3, 2026Retraction Problem
THE NEEDLE JAMMED WHEN THE SAFETY DEVICE WAS ACTIVATED, FAILING TO COMPLETELY ENCAPSULATE THE NEEDLE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247848 ↗MalfunctionJan 30, 2026Retraction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223363 ↗
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-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-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-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-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-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-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 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
- BD Insyte Autoguard Shielded IV Catheter 381834Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days388 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.
How reports and recalls are matched · Editorial policy · Report an error on this page