MEDLINE
Received Jun 5, 2026 · Event occurred Apr 10, 2026
Report 1417592-2026-02165 · MDR key 25417519
Device
Generic name
Single Shot Tray - Dr. Hare
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN0789A
Lot number
25JBG090
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THERE WERE BLACK SPECKS FOUND IN TRAY AND INSIDE LUER CONNECTION ON SYRINGE NEEDLES. ANOTHER TRAY WAS OPENED AND USED. NO INJURY OCCURRED. TRAY AND CONTENTS NOT USED IN PATIENT CARE. 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
THERE WERE BLACK SPECKS FOUND IN TRAY AND INSIDE LEUR CONNECTION ON SYRINGE NEEDLES.