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Henry Schein 1009808Recalls & reported problems

Henry Schein, Inc. · CW Aspirating Syringe · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040004456), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Needle Stick/Puncture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 18, 2023Use of Device Problem; Use of Device Problem

    THE USER FACILITY REPORTED THAT DURING A DENTAL EXTRACTION PROCEDURE A DENTAL ASSISTANT'S FINGER WAS PRICKED BY A NEEDLE ATTACHED TO THEIR 100-9808 ASPIRATING SYRINGE. THE ASSISTANT DISINFECTED THEIR FINGER, SELF-APPLIED A BANDAGE, AND WAS REFERRED TO VISIT THEIR PRIMARY CARE PHYSICIAN.

    Patient problems: Needle Stick/Puncture

    MAUDE report 16763790 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.