MalfunctionFMK

LANCET SAFETY MED FLOW NEEDLE GAUGE

Received Apr 20, 2026 · Event occurred Mar 23, 2026

Report MW5186978 · MDR key 24927686

Device

Generic name

Lancet, Blood

Manufacturer

Cardinal Health 200, Llc.

Model number

SLMF200

Lot number

12743

Product problems

Retraction Problem
Misfire

Patient

NA · Unknown

Unspecified Tissue Injury

Narrative

Description of Event or Problem

THERE HAS BEEN 3 CASES OF NEEDLESTICK INJURY DURING USE OF THIS PRODUCT. BOTH ISSUES HAVE OCCURRED: 1. NOT FIRING (DISCHARGING) AFTER TOP IS TWISTED OFF. 2. AFTER FIRING (DISCHARGING) THE NEEDLE IS STILL EXPOSED (NOT RETRACTING). PT CODE: 4559. DEVICE CODES: 1536, 2532. REF REPORT: MW5186977, MW5186979.