BD Insyte Autoguard Shielded IV CatheterRecalls & reported problems across all models
Becton, Dickinson And Company · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,374
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls
- 0
We found 4 models of BD Insyte Autoguard Shielded IV Catheter by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 1,374 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2017 and Sep 28, 2026 — classified as 49 injuries, 1,325 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (360 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Insyte Autoguard Shielded IV Catheter problems
Device problems
- Retraction Problem360
- Leak/Splash284
- Device Contamination with Chemical or Other Material174
- Break117
- Material Puncture/Hole68
- Defective Component48
- Material Protrusion/Extrusion42
- Material Split, Cut or Torn35
Patient problems
- No Clinical Signs, Symptoms or Conditions757
- No Known Impact Or Consequence To Patient317
- No Consequences Or Impact To Patient115
- Insufficient Information50
- No Patient Involvement45
- Pain28
- Needle Stick/Puncture21
- Foreign Body In Patient16
BD Insyte Autoguard Shielded IV Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Insyte Autoguard Shielded IV Catheter 381823Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard Shielded IV Catheter 381834Catheter, intravascular, therapeutic, short-term less than 30 days388 reports
- BD Insyte Autoguard Shielded IV Catheter 381812Catheter, intravascular, therapeutic, short-term less than 30 days304 reports
- BD Insyte Autoguard Shielded IV Catheter 381844Catheter, intravascular, therapeutic, short-term less than 30 days100 reports
Recent BD Insyte Autoguard Shielded IV Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923608 ↗MalfunctionSep 28, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922147 ↗MalfunctionSep 24, 2026Retraction Problem
It was reported that BD INSYTE AUTOGUARD needle did not retract.It was reported that safety device did not function.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885990 ↗MalfunctionSep 24, 2026Material Perforation; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881897 ↗InjurySep 23, 2026Break
It was reported that BD INSYTE AUTOGUARD catheter broke and portion was retained.patient (b)(6), admitted on (b)(6) 2026, to the UCO Unit, Bed 28, developed delirium during hospitalization, presenting with psychomotor agitation and loss of peripheral venous access via a 18 MDS Jelco catheter. Following the incident, the tip of the Jelco catheter was found to be retained in the right upper limb (MDS). The Cardiovascular Surgery (CCV) team was called in to attempt its removal, but the procedure was unsuccessful.
Patient problems: Foreign Body In Patient
MAUDE report 50873049 ↗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 ↗MalfunctionSep 22, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859145 ↗MalfunctionSep 22, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859135 ↗MalfunctionSep 15, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775096 ↗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 30, 2026Retraction Problem
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. SAFETY DEVICE IS NOT WORKING PROPERLY. NEEDLE IS NOT BEING RETRACTED WHEN THE SAFETY DEVICE IS ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667628 ↗
Other Becton, Dickinson And Company products
- BD Vacutainer SST10 models · 4,985 reports · 3 recalls
- BD Luer-Lok48 models · 5,117 reports
- BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
- BD SafetyGlide17 models · 2,185 reports
- BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
- BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
- BD Nexiva25 models · 1,614 reports · 1 recall
- BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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