AutoShield Duo 329515Recalls & reported problems
Embecta Medical II, LLC · AutoShield Duo™ Pen Needles, 5mm, 30G, 3bevel, TW · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383017951535), received between Feb 17, 2026 and Mar 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Activation1
- Material Protrusion/Extrusion1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026
WHILE ATTEMPTING TO SCREW NEEDLE ONTO THE END OF THE INSULIN PEN, THE SPRING CAME OUT AND DEVICE FELL APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589504 ↗MalfunctionFeb 17, 2026Difficult or Delayed Activation; Material Protrusion/Extrusion
MEDWATCH REPORT (B)(4) ATTACHED TO THIS CASE. UNABLE TO OPEN THE REPORT LOT # UNKNOWN CATALOG# UNKNOWN DATE OF EVENT UNKNOWN AT THIS TIME SAMPLE STATUS NO. (B)(6), (B)(6) 2026: AS PER THE ATTACHED REPORT. DESCRIBE THE EVENT OR PROBLEM: RN ADMINISTERING INSULIN SQ [SUB-CUTANEOUS] TO PATIENT. NEEDLE DID NOT SELF-RETRACT. NEEDLE STICK INJURY TO WRITER. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: INJECT INSULIN AND PREVENT STAFF NEEDLE STICK WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. VCOYNE (B)(6) 2026 UPDATE/ADDITIONAL INFORMATION FROM NACC - SEE ATTACHMENTS. LOT # 4311022 EVENT NEEDLE STICK TO STAFF AFTER INJECTING PATIENT. "NEEDLE DID NOT SELF-RETRACT. NEEDLE STICK TO WRITER AFTER INJECTION" MEDWATCH REPORT (B)(4). DESCRIBE THE EVENT OR PROBLEM: RN ADMINISTERING INSULIN SQ [SUB-CUTANEOUS] TO PATIENT. NEEDLE DID NOT SELF-RETRACT. NEEDLE STICK INJURY TO WRITER. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? INJECT INSULIN AND PREVENT STAFF NEEDLE STICK-- WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKIN
Patient problems: Needle Stick/Puncture
MAUDE report 24366932 ↗
Other Needle, hypodermic, single lumen devices
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- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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