Introducer Needle S03021-275Recalls & reported problems
Bard Access Systems, Inc. · SecLoc,INTRO 21Gx2.75 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741041716), received between Jul 10, 2020 and May 15, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (3 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.
Most reported problems
Device problems
- Activation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT "GREEN SAFETY MECHANISM BROKE OFF OF THE NEEDLE" NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16935823 ↗MalfunctionJul 16, 2021Activation Problem; Activation Problem
IT WAS REPORTED "WE HAD A SECURELOC WHERE THE BASE OF THE LOCKING SYSTEM (GREEN PART) WAS NOT CONNECTED OR DAMAGED. THERE WAS NO CAREGIVER OR PATIENT HARM AS IT WAS NOTICED IMMEDIATELY." NO OTHER INFORMATION PROVIDED. ADD INFO RCVD 07/06/2021: DATE OF OCCURRENCE: (B)(6) 2021. PLACEMENT INFO: ATTEMPTED TO UTILIZE SECURELOC, PROCEDURALIST NOTICED THE GREEN PART OF THE NEEDLE WAS DAMAGED AND HAD A BROKEN PIECE. THE NEEDLE WAS NOT USED FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12182732 ↗MalfunctionJul 10, 2020Activation Problem; Activation Problem
IT WAS REPORTED FACILITY HAD AN ISSUE YESTERDAY WITH THE BARD SECURELOCK SAFETY INTRODUCER NEEDLE LOT # REEP3239. AFTER ACCESSING AND THREADING THE WIRE INTO THE VEIN, THE PROCEDURALIST REMOVED THE NEEDLE AND PULLED THE GREEN SAFETY SLIDE DOWN TOWARD THE TIP OF THE NEEDLE. THE GREEN SLIDE ACTUALLY SLIDE PAST THE NEEDLE TIP AND COMPLETELY OFF EXPOSING THE TIP OF THE NEEDLE THAT WAS UTILIZED TO ACCESS THE PATIENT¿S VEIN.THIS NEEDLE WAS NOT IN THE CUSTOM KITS BUT DROPPED INDEPENDENTLY ONTO THE STERILE FIELD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10258664 ↗
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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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