Insyte Autoguard 382923Recalls & reported problems
Becton, Dickinson And Company · BD Insyte™ Autoguard™ BC Pro Winged 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
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903829231), received between Oct 4, 2022 and Jan 7, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (6 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 Problem6
- Leak/Splash3
- Device Contamination with Chemical or Other Material2
- Activation Problem1
- Contamination1
- Defective Component1
- Difficult or Delayed Activation1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Ecchymosis1
- Insufficient Information1
- Needle Stick/Puncture1
- Pain1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Retraction Problem
THE SAFETY MECHANISM DID NOT ACTIVATE WHEN THE CATHETER AUTOGUARD WAS FITTED, DESPITE THE RETRACTION BUTTON BEING PRESSED SEVERAL TIMES. RESPONSE RECEIVED ON: 1/2/2026. THE DEVICE WAS INSTALLED ON THE PATIENT AND DID NOT RETRACT WHEN THE SAFETY MECHANISM WAS ACTIVATED. FORTUNATELY, THE PATIENT DID NOT SUFFER ANY DAMAGE TO HIS VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23996363 ↗MalfunctionOct 29, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem
MalfunctionOct 17, 2025Retraction Problem; Difficult or Delayed Activation; Retraction Problem; Difficult or Delayed Activation
THE NURSE WAS UNABLE TO ASSEMBLE THE CATHETER AND FOUND IT IMPOSSIBLE TO RETRACT THE NEEDLE AFTER THE PUNCTURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S ARM AS IT WAS. NO MAJOR TRAUMA WAS OBSERVED, ONLY A SLIGHT BRUISE AT THE PUNCTURE SITE. DATE OF EVENT UNKNOWN.
Patient problems: Ecchymosis
MAUDE report 23330489 ↗MalfunctionSep 16, 2025Retraction Problem; Retraction Problem
PRICK WITH CONTAMINATED NEEDLE AFTER KTR INSERTION IN A PATIENT. MATERIAL DEFECT, THE NEEDLE WAS NOT COMPLETELY RETRACTED AND WHEN IT WAS THROWN AWAY THE NEEDLE WENT BACK INTO THE THUMB. 9/5/2025 CUSTOMER RESPONSE: HAS THE PATIENT OR USER SUFFERED HARM? IF YES, PLEASE EXPLAIN YES, AES FOR CARE STAFF. DID THE MALFUNCTION CAUSE A NEEDLESTICK INJURY TO HEALTHCARE STAFF OR THE PATIENT? YES, CARE STAFF. WERE HEALTHCARE PERSONNEL EXPOSED TO BLOOD OR BODY FLUIDS? YES. WAS THERE A PROBLEM WITH THE SAFETY DEVICE? YES. WERE OTHER MEASURES TAKEN? FOLLOW-UP OF INTERNAL PROCEDURE IN THE EVENT OF AN AES. RESPONSE ON 12-SEP-2025. HERE IS THE DEPARTMENT'S RESPONSE: "THE STAFF MEMBER CONCERNED WENT TO A&E TO REPORT THE INCIDENT AND COMPLETE THE VARIOUS PAPERWORK. A BLOOD SAMPLE WAS TAKEN FROM THE PATIENT AND THE AGENT HIMSELF. I'M NOT AWARE OF THE RESULTS. BUT FOLLOW-UP IS UNDERWAY."
Patient problems: Needle Stick/Puncture
MAUDE report 23064968 ↗MalfunctionAug 13, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING NEEDLE RETRACTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING TREATMENT, THE DEVICE'S CANULA DID NOT RETRACT, EXPOSING THE NURSE TO A RISK OF PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797971 ↗MalfunctionJan 3, 2025Contamination; Contamination
IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL WING FOREIGN MATTER ON CATHETER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT ABNORMAL CATHETER TIP FOUND BEFORE USE. ACCORDING TO THE CUSTOMER REPORT BURR-LIKE OBJECT FOUND TO BE ADHERED TO THE TIP OF THE CATHETER BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072172 ↗MalfunctionNov 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20729969 ↗MalfunctionNov 19, 2024Premature Separation; Premature Separation
MalfunctionOct 30, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHC COMPLAINT REFERENCE #: (B)(4). HOSPITAL COMPLAINT REFERENCE #: (B)(4). CUSTOMER (HOSPITAL) NAME: (B)(6). CUSTOMER ADDRESS: (B)(6). CONTACT NAME: (B)(6). PHONE: (B)(6). E-MAIL: (B)(6). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD382923 DESCRIPTION OF PRODUCT: CATHETER INS AG WGD 22GX25MM 50 EA/BX 4 BX/CA (200). LOT OR S/N: (B)(6) COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO INCIDENT DATE: UNKNOWN HOSPITAL COMPLAINT REFERENCE #:(B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): "NURSE WAS STARTING AN IV ON A PATIENT, THE CATHETER NEEDLE DID NOT RETRACT WHEN THE NURSE PRESSED ON THE BUTTON TO RETRACT THE NEEDLE." INCIDENT DATE AND IF PATIENT INJURY OCCURRED UNKNOWN. ADDITIONAL INFORMATION WILL BE SENT VIA SEPARATE EMAIL. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO QTY AFFECTED: 1 EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571565 ↗MalfunctionOct 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL FOREIGN MATTER EVIDENCED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT FOREIGN OBJECT CONTAMINATION FOUND ON THE PRODUCT BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464812 ↗MalfunctionMar 25, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18967311 ↗MalfunctionMar 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING IS LEAKING AT THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: DURING 3 CONSECUTIVE USES IN DIFFERENT PATIENTS, WE ENCOUNTERED A LEAKAGE OF IODINATED CONTRAST MEDIUM AT THE JUNCTION POINT BETWEEN THE CATHETER AND THE CONNECTOR, DESPITE THE SCREW THREAD BEING PROPERLY TIGHTENED. WE ONLY HAD ONE BATCH OF EACH DEVICE AVAILABLE IN THE DEPARTMENT, SO IT WAS NOT POSSIBLE TO PRECISELY IDENTIFY THE MALFUNCTIONING DEVICE. WE QUARANTINED THE BLUE CATHETERS. ¿ HAS THERE BEEN AN IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE IN TREATMENT NEEDED)? NO IMPACT ON THE PATIENT EXCEPT FOR THE LEAKAGE OF CONTRAST MEDIUM ON THE EXAMINATION TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18967264 ↗MalfunctionMar 20, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL WING IS LEAKING AT THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING 3 CONSECUTIVE USES IN DIFFERENT PATIENTS, WE ENCOUNTERED A LEAKAGE OF IODINATED CONTRAST MEDIUM AT THE JUNCTION POINT BETWEEN THE CATHETER AND THE CONNECTOR, DESPITE THE SCREW THREAD BEING PROPERLY TIGHTENED. WE ONLY HAD ONE BATCH OF EACH DEVICE AVAILABLE IN THE DEPARTMENT, SO IT WAS NOT POSSIBLE TO PRECISELY IDENTIFY THE MALFUNCTIONING DEVICE. WE QUARANTINED THE BLUE CATHETERS. HAS THERE BEEN AN IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE IN TREATMENT NEEDED)? NO IMPACT ON THE PATIENT EXCEPT FOR THE LEAKAGE OF CONTRAST MEDIUM ON THE EXAMINATION TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941525 ↗MalfunctionDec 5, 2023Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18270887 ↗MalfunctionJun 13, 2023Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY THE DEVICE WAS DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A WING DEFORMATION OF IAG BC. BEFORE USE, THE HCP NOTICED THAT THE WING OF THE PRODUCT WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17122635 ↗MalfunctionOct 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A HOLE WAS FOUND IN THE PAPER SIDE OF THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER UNIT PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT A DAMAGED PACKAGE OF IAGBC. ACCORDING TO THE CUSTOMER'S REPORT, A HOLE WAS FOUND ON THE PAPER SIDE OF THE PACKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15535301 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
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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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