Introducer Needle S03421-275Recalls & reported problems
Bard Access Systems, Inc. · SecLc,INTR 21Gx2.75 ST · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741041815), received between Dec 9, 2022 and Aug 5, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem2
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE NEEDLE DID NOT SAFETY- NEEDLE EXPOSED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723233 ↗MalfunctionAug 5, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DID NOT SAFETY - NEEDLE EXPOSED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723232 ↗MalfunctionJan 18, 2024
WHEN ATTEMPTING TO CANNULATE VEIN FOR PICC PLACEMENT. NOTED INTRODUCER NEEDLE WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535284 ↗MalfunctionDec 9, 2022Difficult to Insert
DURING INSERTION OF SURELOCK SAFETY INTRODUCER NEEDLE VASCULAR ACCESS RN EXPERIENCED DIFFICULTY PUNCTURING SKIN. NOTED THERE WAS NO SIGN OF HITTING ANY TENDON OF MUSCLE THROUGH ULTRASOUND. DUE TO DIFFICULTY PUNCTURING VEIN, HAD TO THREAD NEEDLE IN BEFORE PUNCTURING SKIN AND INSERTING GUIDEWIRE. RN WAS ULTIMATELY ABLE TO ACCESS TARGET VEIN SAFELY WITH NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949791 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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