MEDLINE
Received Apr 14, 2026 · Event occurred Mar 25, 2026
Report 1417592-2026-00435 · MDR key 24880306
Device
Generic name
Needle, Quincke, 22gx3.5"
Manufacturer
Medline Industries, LpCatalog number
PAIN8017
Lot number
25KBN785
Product problems
- Difficult to Open or Remove Packaging Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AS THE TECH WAS OPENING THE NEEDLE TO PUT IT ON THE STERILE TRAY, THE PACKAGE RIPPED ABOUT HALFWAY DOWN THE PACKAGE CAUSING THE NEEDLE TO EITHER TOUCH THE OUTSIDE PACKAGING OR THEIR HAND. AFTER THIS ACTION OCCURRED ANOTHER NEEDLE HAD TO BE OPENED SO THAT THERE WAS NO RISK FOR ADDING A CONTAMINATED NEEDLE TO THE STERILE FIELD. THERE WAS NO PATIENT, NO DEATH, INJURY, FOLLOW-UP CARE, MEDICAL, OR SURGICAL INTERVENTION OR TREATMENT REQUIRED.
Description of Event or Problem
THE PACKAGE TEARS ABOUT HALFWAY MAKING IT HARD TO SLIDE THE NEEDLE OUT OR IT CONTAMINATES BY FLIPPING OUT.
Additional Manufacturer Narrative
ADDED H6 (B) TYPE OF INVESTIGATION 3330, 3331, 4221, 4110, 4121; (C) 171 PACKAGING FOR INVESTIGATION FINDINGS, AND 23 MANUFACTURING FOR CONCLUSION.