Henry Schein 9007651Recalls & reported problems
Henry Schein, Inc. · Needle Disposable Safety · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040017258), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fail-Safe Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 31, 2022Detachment of Device or Device Component; Fail-Safe Problem
PHLEBOTOMIST WAS COLLECTING BLOOD SAMPLE WHEN NEEDLE SEPARATED FROM THE BASE AND SAFETY DEVICE. THE NEEDLE REMAINED IN THE PATIENT'S ARM AND HAD TO BE REMOVED BY HAND, AND SAFETY DEVICE COULD NOT BE ENGAGED. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 13417134 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.