Insyte Autoguard 381023Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.00 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Insyte Autoguard IV catheter is a short-term shielded catheter for placing an IV line. Of its 173 reports, 6 are filed as injuries, and most describe the needle failing to fully retract after use, along with leaks and packaging problems. One injury report describes the catheter breaking and part of it remaining in the patient, which had to be removed surgically; the reports mention no deaths, and 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
- 173
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00382903810239), received between Jul 18, 2018 and Sep 30, 2026 — classified as 6 injuries, 167 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (43 reports).
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 Problem43
- Leak/Splash34
- Material Frayed15
- Packaging Problem15
- Defective Component13
- Contamination10
- Device Contamination with Chemical or Other Material9
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- No Known Impact Or Consequence To Patient11
- Insufficient Information7
- Foreign Body In Patient5
- Pain5
- Ecchymosis2
- Needle Stick/Puncture2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash
It was reported that BD INSYTE AUTOG BC GLOBAL leaked beyond the blood control feature.Reported blood splatter from the rear end of the safety barrel during blood collectionDetailed Safety Issue: Risk of Infection from Blood Splatter
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946181 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was determined through the investigation that BD INSYTE AUTOG BC GLOBAL needle was damaged or defective. Customer report: t was reported that "The tip of the catheter needle became deformed during the patient's infusion"Actions taken at the healthcare facility to manage the patient: The faulty device was removed. Another device was used.Response Received on:7/27/2026When was the defect identified? During or after use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933033 ↗MalfunctionJun 11, 2026Retraction Problem
THE CUSTOMER COMPLAINED THAT THE NEEDLE COULD NOT BE FULLY RETRACTED AFTER USE.WAS THERE ANY IMPACT TO A PATIENT, HCP, USER OR OTHER? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474086 ↗InjuryMay 27, 2026Break
IT WAS REPORTED THAT CATHETER BROKE/SEPARATED. IT WAS REPORTED THAT SVH HAVE HAD TO SURGICALLY REMOVE THE CANNULA OF THIS PRODUCT AFTER IT WAS RETAINED. I AM STILL WORKING THROUGH THE EVENTS LEADING UP TO THIS HOWEVER IT'S BELIEVED IT HAS BEEN RETAINED FOR ABOUT 5 WEEKS WHICH MAKES IT DIFFICULT TO ASCERTAIN THE LOT NUMBER. 14-MAY-2026 PLEASE CONFIRM THAT THE CATHETER BROKE OFF AND REMAINED IN THE PATIENT. YES. WHERE ON THE CATHETER TUBING DID THE CATHETER BREAK? DID THE CATHETER SEPARATE FROM THE ADAPTER, OR DID IT BREAK OFF SOMEWHERE ALONG THE CATHETER TUBING LENGTH? BY MEASURING IT AGAINST AN INTACT CATHETER IT APPEARS THAT IT BROKE AT THE WELD WITH THE HUB. WHAT WAS THE CATHETER BEING USED FOR AT THE TIME OF THE FAILURE? IVF WAS A POWER INJECTOR BEING USED? I WILL DOUBLE-CHECK THIS HOWEVER DO NOT BELIEVE SO AS THE PATIENT WAS A SURGICAL PATIENT UNDER ONCOLOGY.
Patient problems: Foreign Body In Patient
MAUDE report 25302625 ↗MalfunctionMay 18, 2026Retraction Problem
ACCORDING TO THE CUSTOMER¿S REPORT, THE NEEDLE DID NOT RETRACT DURING USE WHEN THE NEEDLE RETRACTION BUTTON WAS PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203700 ↗MalfunctionMay 15, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THIS IS A REPORT ABOUT NEEDLE RETRACTION FAILURE. ACCORDING TO THE CUSTOMER REPORT, AFTER PUNCTURING THE PATIENT, AN ATTEMPT WAS MADE TO PRESS THE BUTTON TO RETRACT THE NEEDLE; HOWEVER, THE MECHANISM STOPPED HALFWAY, AND THE NEEDLE DID NOT FULLY RETRACT AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25190353 ↗MalfunctionMay 15, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE WAS SLOW TO RETRACT. ACCORDING TO THE CUSTOMER REPORT, EVEN AFTER PRESSING THE SAFETY DEVICE ACTIVATION BUTTON AFTER INSERTION, THE INNER NEEDLE DID NOT RETRACT DURING USE. THE INNER NEEDLE REMAINED EXPOSED, BUT IT RETRACTED AFTER BEING TILTED AND TOUCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183420 ↗MalfunctionApr 28, 2026Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016623 ↗MalfunctionApr 21, 2026Retraction Problem
ACCORDING TO THE CUSTOMER REPORT, THE NEEDLE DOES NOT RETRACT AFTER PUNCTURING THE PATIENT DURING USE. DETAILED SAFETY ISSUE - LEADING TO NEEDLESTICK ACCIDENTS. WAS THERE A NEEDLESTICK INJURY THAT OCCURRED? I DON'T THINK SO, BECAUSE HE DIDN'T SAY ANYTHING IN PARTICULAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945135 ↗InjuryApr 20, 2026Break
MalfunctionApr 11, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE ONLY RETRACTED PARTWAY. THE CUSTOMER CONFIRMED ABOUT AN HOUR LATER THAT IT HAD FULLY RETRACTED DUE TO VIBRATION DURING USE. THE NEEDLE RETRACTION IS SLUGGISH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846010 ↗MalfunctionApr 9, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832435 ↗MalfunctionApr 9, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. IT WAS REPORTED THAT DURING THE INSERTION OF THE VENOUS LINE, THE NEEDLE DID NOT RETRACT, EVEN THOUGH THE WHITE BUTTON WAS PRESSED. THE NEEDLE REMAINS EXTENDED, WHICH IS THEREFORE DANGEROUS. // OPCT BOX, ISOLATE THE NON-RETRACTED NEEDLE, CHECK FOR A CATHETER WITH THE SAME BATCH NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832432 ↗MalfunctionApr 6, 2026Leak/Splash; Connection Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792448 ↗MalfunctionMar 31, 2026Crack; Leak/Splash
IT WAS REPORTED THAT THERE WAS A CRACK IN A CATHETER. NURSE INSERTED CANNULA AND EXPERIENCED BLOOD LEAKAGE. INJECTED AGAIN AND WITH SAME CANNULA AND AGAIN EXPERIENCED LEAKAGE. IDENTIFIED A CRACK IN THE CANNULA. USED ANOTHER CANNULA AND IT WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747028 ↗MalfunctionMar 30, 2026Retraction Problem
IT WAS REPORTED THAT THE NURSE WAS ACCIDENTALLY PRICKED BECAUSE THE NEEDLE DID NOT FULLY RETRACT. ONCE THE DEVICE (NEEDLE CANNULA) WAS POSITIONED AND THE BUTTON TO RETRACT THE NEEDLE WAS PRESSED, THE NURSE WAS ACCIDENTALLY PRICKED BECAUSE THE NEEDLE DID NOT FULLY RETRACT AND ABOUT 1 CM OF THE TIP REMAINED EXPOSED.
Patient problems: Needle Stick/Puncture
MAUDE report 24713028 ↗MalfunctionMar 30, 2026Premature Separation
THIS MDR IS A RESULT OF AN INVESTIGATION FINDING HOWEVER THE CUSTOMER REPORTED THAT THE CATHETER RELEASED PREMATURELY. THE CUSTOMER STATES THAT WHEN THE CAP WAS REMOVED, EVEN THE OUTER CASING CAME OFF BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712757 ↗MalfunctionMar 20, 2026Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648256 ↗MalfunctionMar 19, 2026Contamination
IT WAS REPORTED THAT FOREIGN MATER WAS FOUND ON THE CATHETER. ¿I PREPARED TO INSERT AN IV CATHETER AS ORDERED ON THIS PATIENT. AFTER SWABBING THE INSERTION SITE WITH ALCOHOL, I OPENED NEW A 22 GAUGE IV CATHETER. BEFORE INSERTING THE CATHETER, I INSPECTED IT PER STANDARD PROTOCOL AND NOTICED A SMALL METAL SHAVING ON THE TIP OF THE CATHETER. THE CATHETER WAS NOT INSERTED INTO THE PATIENT AND WAS IMMEDIATELY SET ASIDE. AFTER CAPPING THE DEFECTIVE CATHETER, I STORED IT ALONG WITH ITS PACKAGING IN A SEPARATE AREA, INFORMED THE CHARGE NURSE, AND EMAILED MY MANAGER WITH THE INFORMATION REGARDING THE EVENT, THE LOT NUMBER OF THE CATHETER, AND THE EXPIRY DATE.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644078 ↗MalfunctionMar 16, 2026Leak/Splash; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605281 ↗MalfunctionMar 6, 2026Nonstandard Device
IT WAS REPORTED THAT CONNECTION ISSUES OCCURRED. THE INVESTIGATION CONFIRMED THAT THERE WAS DAMAGE TO THE ADAPTOR. THERE IS A POOR FIT WITH THE INFUSION LINE. POOR CONNECTION WITH THE INFUSION LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532594 ↗MalfunctionMar 5, 2026Retraction Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518235 ↗MalfunctionMar 4, 2026Contamination
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE CATHETER TIP. ACCORDING TO THE CUSTOMER REPORTS, THE CATHETER COULD NOT BE USED BECAUSE A BLACK FOREIGN MATERIAL WAS FOUND AT ITS TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508545 ↗MalfunctionMar 3, 2026Retraction Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. THE SAFETY MECHANISM DID NOT ACTIVATE WHEN THE BUTTON WAS PRESSED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497460 ↗MalfunctionFeb 27, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474823 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
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- 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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