Henry Schein 9007656Recalls & 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 00304040017302), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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
- Material Protrusion/Extrusion1
Patient problems
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2022Material Protrusion/Extrusion
THE CUSTOMER REPORTS THAT A PRE-PROCEDURE PREP OF LIDOCAINE WAS BEING ADMINISTERED TO A (B)(6) MALE PATIENT. THE PROCEDURE SCHEDULED WAS A LUMBAR EPIDURAL STEROID INJECTION. THE PROCEDURE WAS NOT PERFORMED DUE TO THE NEEDLE COMING OUT OF THE HILT/HUB. THE NEEDLE THEN BECAME LODGED IN THE SOFT TISSUE OF THE PATIENT'S LUMBAR. AS A RESULT THE PATIENT WAS SENT TO THE OPERATING ROOM ON (B)(6) 2022. THE SAME DAY, ON (B)(6) 2022 THE PATIENT WAS DISCHARGED. THE PATIENT IS DOING WELL AS OF TODAY. THE PAIN THEY ARE EXPERIENCING IS BEING CONTROLLED BY OTC. THE ONE USING THIS HAS USED THESE TYPE BEFORE.
Patient problems: Device Embedded In Tissue or Plaque; Pain
MAUDE report 14892657 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.