MEDLINE
Received Jun 15, 2026 · Event occurred May 18, 2026
Report 1417592-2026-02431 · MDR key 25513144
Device
Generic name
Needle, Quincke, 22gx3.5"
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN8017
Lot number
NEEDLE, QUINCKE, 22GX3.5"
Product problems
- Unsealed Device Packaging
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PACKAGING FOR THE NEEDLES ARRIVED UNSEALED. AFTER, THE NEEDLES WERE SAVED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
THE REPORTED ISSUE IS THAT THE PACKAGING FOR THE NEEDLES ARRIVED UNSEALED.