Insyte Autoguard 381012Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 24 GA x 0.75 IN · Class 2
All models of Insyte Autoguard (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD Insyte Autoguard BC Pro Shielded IV catheter, a short-term intravenous line with a blood-control needle. The 72 reports mostly describe blood leaking or splashing from the hub, the safety button failing to retract the needle after puncture, and cracks or holes in the tubing or hub. There are no deaths and no injuries, and no recalls name this device. Reports fell from 27 in the earlier 12 months to 16 in the most recent 12 months.
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
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382903810123), received between Jul 16, 2018 and Jun 16, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (26 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
- Leak/Splash26
- Retraction Problem16
- Crack8
- Fluid/Blood Leak7
- Defective Component6
- Material Puncture/Hole4
- Connection Problem3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- No Known Impact Or Consequence To Patient7
- Insufficient Information2
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Retraction Problem
ACCORDING TO THE CUSTOMER REPORT, THERE WAS NO MOVEMENT OF THE NEEDLE WHEN THE BUTTON WAS PRESSED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526677 ↗MalfunctionJun 1, 2026Material Puncture/Hole
IT WAS REPORTED THAT CUSTOMER PUNCTURED THE CATHETER AND FED IT, BUT WHEN THEY LOOKED AT THE CATHETER, THEY THOUGHT IT WASN'T GOING VERY FAR, SO THEY LOOKED AT THE CATHETER AND SAW THAT IT WAS STICKING THROUGH DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351469 ↗MalfunctionMay 18, 2026Retraction Problem
ACCORDING TO THE CUSTOMER REPORT, AFTER CATHETER PLACEMENT, THE INNER NEEDLE DID NOT RETRACT EVEN WHEN THE SAFETY DEVICE ACTIVATION BUTTON WAS PRESSED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203702 ↗MalfunctionMar 19, 2026Product Quality Problem; Retraction Problem
IT WAS REPORTED THAT NEEDLE HUB DAMAGE RESULTED IN RETRACTION FAILURE. IT WAS REPORTED THAT THE NEEDLE FAILED TO FUNCTION PROPERLY DUE TO A SAFETY FEATURE MALFUNCTION AND BUTTON DAMAGE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644087 ↗MalfunctionMar 17, 2026Leak/Splash
IT WAS REPORTED THAT THE DEVICE LEAKS AT THE HUB. TODAY THE ED STAFF IDENTIFIED ISSUES WITH THE 24G X 0.75 INCH AUTOGUARD BD IV CATHETER. THERE IS LEAKING AT THE HUB OF THIS DEVICE WHEN FLUSHING, SIMILAR TO THE ISSUES WE FACED ABOUT 1 YEAR AGO. I BELIEVE THE AFFECTED LOT # 5197339. WE HAVE PULLED THIS LOT NUMBER FROM THE DEPARTMENT AND OUR XX IS UPDATING STORES AS WELL. NEED NEW IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618427 ↗MalfunctionMar 16, 2026Crack
IT WAS REPORTED THAT THE HUB WAS CRACKED. ACCORDING TO THE CUSTOMER¿S REPORT, A CRACK WAS FOUND AT THE NEEDLE CONNECTION DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605271 ↗MalfunctionMar 4, 2026Contamination
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ADHERED TO THE TIP OF THE CATHETER BEFORE USE. UNABLE TO USE DUE TO FOREIGN MATTER ON THE TIP OF CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508541 ↗MalfunctionFeb 20, 2026Contamination
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401054 ↗MalfunctionDec 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER PUNCTURE, SALINE SOLUTION LEAKED OUT AT THE CONNECTION TO THE THERMO EXTENSION TUBE DURING USE. LEAKING OUT FROM THE CONNECTOR, PROBABLY SALINE SOLUTION, NOT ANTI-CANCER DRUG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903517 ↗MalfunctionDec 22, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23870658 ↗MalfunctionDec 18, 2025Leak/Splash; Material Perforation; Leak/Splash; Material Perforation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837950 ↗MalfunctionDec 9, 2025Retraction Problem; Retraction Problem
THE CUSTOMER COMPLAINED THAT THE NEEDLE RETRACTED SLOWLY AFTER BUTTON ACTIVATION. WAS AFFECTED PRODUCT USED ON A PATIENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764370 ↗MalfunctionDec 9, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23764207 ↗MalfunctionNov 19, 2025Crack; Leak/Splash; Crack; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598698 ↗MalfunctionNov 14, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560464 ↗MalfunctionOct 28, 2025Leak/Splash; Leak/Splash
CUSTOMER STATES" VARIOUS PIVC INSERTERS FROM RADIATION ONCOLOGY UNIT HAVE EXPERIENCED B;OOD CONTROL FAILURE ON THE 22G AND DIFFICULTY INSERTING 24G- EXCESSIVE RESISTANCE TO NEEDLE ENTRY. NURSES STATE, NEEDLE LOOKS BLUNT. CNC VASE EXAMINED 24G AND STATES THERE IS AN OBVIOUS FLAW IN PLASTIC CATHETER WHICH WOULD RESULT IN PAINFUL OR FAILED CANNULATION 24-OCT-2025 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT. COULD YOU PLEASE CONFIRM IF THE COURSE OF TREATMENT CHANGED DUE TO EVENT? NO. COULD YOU PLEASE CONFIRM IF THERE WAS ANY EXPOSURE TO BLOOD/BODILY FLUID? YES. AS THE SAFETY VALVE HAD A DEFECT, THERE WAS BLOOD RETURN FROM THE PIVC BUT NURSES WERE FOLLOWING THE CORRECT PROCEDURE BY USING UNIVERSAL PRECAUTIONS. COULD YOU PLEASE CONFIRM IF THIS IS A SAFETY ISSUE? IF A NURSE IS CANNULATING A PATIENT WHO IS ON CYTOTOXIC PRECAUTIONS AND THERE IS A BLOOD SPILL; OR IF NURSES ARE NOT FOLLOWING PROCEDURES USING UNIVERSAL PRECAUTION. NOT MENTION EXPOSURE TO HEPATITIS/HIV PATIENTS. COULD YOU PLEASE CONFIRM IF ANY OTHER ACTIONS WERE TAKEN? VASE AND QUALITY DEPARTMENT NOTIFIED. RTU NURSES NOTIFIED AND AWARE OF THE POSSIBLE PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402213 ↗MalfunctionSep 16, 2025Defective Component; Material Integrity Problem; Defective Component; Material Integrity Problem
SPECIFICALLY, THERE IS NO SHARPNESS, AND IT COULD NOT PENETRATE THE SKIN (EPIDERMIS) (DID NOT REACH THE BLOOD VESSEL). WHEN A NEW ONE WAS OPENED AND PUNCTURED AGAIN, IT COULD BE PUNCTURED AS USUAL WITHOUT ANY PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064618 ↗MalfunctionSep 11, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031358 ↗MalfunctionSep 2, 2025Defective Component; Defective Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932991 ↗MalfunctionAug 18, 2025Defective Component; Defective Component
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22829837 ↗MalfunctionJul 17, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534078 ↗MalfunctionJul 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL BLOOD LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT BLOOD LEAKED OUT FROM THE CATHETER HUB DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436940 ↗MalfunctionJul 1, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL HUB CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD LEAKED OUT DUE TO THERE WERE CRACKS IN THE CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375416 ↗MalfunctionJul 1, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE RETRACTED PREMATURELY THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE RETRACTION BUTTON NOT RETRACTING APPROPRIATELY. IV ATTEMPTED X 2 ON PATIENT AND THE NEEDLE RETRACTED WITHOUT NURSE PUSHING THE BUTTON. BOTH SITES WERE LOST ON PATIENT BECAUSE IT RETRACTED TOO SOON. (B)(6) 2025, 1 PATIENT BUT HAPPENED TWICE IN A ROW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22374178 ↗MalfunctionJun 26, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS THE CLINICAL NURSE EDUCATOR FOR BD I WAS OBSERVING SOME CANNULATIONS. WE HAD RECEIVED COMPLAINTS THAT THE 24-GAUGE CANNULA WAS NOT ADVANCING PROPERLY AND THAT AT TIMES THE NEEDLE WAS NOT RETRACTING. MYSELF AND THE IV NURSE SPECIALIST OBSERVED 10 CANNULAS BEING INSERTED AND THERE WAS NO OBVIOUS SIGN OF THIS ISSUE. ONE OF THE NURSING STAFF ASKED IF SHE COULD TRY ON THE VEIN BOARD I HAD WITH ME. IT WAS VERY OBVIOUS THAT THE CANNULA WAS DIFFICULT TO THREAD OFF. I OBSERVED THE NURSE TURNING THE CANNULA TO LOOSEN IT PRIOR TO INSERTION HOWEVER IT WAS VERY STIFF. THE NURSE INFORMED ME THAT THIS IS HAPPENING FREQUENTLY. IT IS DIFFICULT FOR THE NURSING STAFF TO RETAIN THE PRODUCT AS THEY ARE STILL MANAGING TO GET THE CANNULA INTO THE PATIENT HOWEVER NOT WITH THE SAME EASE. ADDITIONALLY, THEY ARE HAVING SOME CANNULAS THAT THE NEEDLE IS NOT RETRACTING. I HAVE ASKED THE STAFF TO KEEP ANY CANNULAS THAT THEY ARE HAVING ISSUES WITH AND THAT THEY WILL BE ABLE TO SEND BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340637 ↗
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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