MEDLINE
Received Apr 14, 2026 · Event occurred Mar 25, 2026
Report 1417592-2026-00419 · MDR key 24875198
Device
Generic name
Needle, Quincke, 25gx3.5"
Manufacturer
Medline Industries, LpCatalog number
PAIN8018
Lot number
25KBM792
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDED H6 (B) INVESTIGATION TYPES, BUT THERE WAS NO CHANGE TO THE FINDINGS OR CONCLUSION.
Additional Manufacturer Narrative
ON (B)(6) 2026, IT WAS REPORTED THAT "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 REPORTED INJURY OR DEATH, AND NO FOLLOW-UP CARE, MEDICAL, AND/OR SURGICAL INTERVENTION OR TREATMENT REQUIRED.
Description of Event or Problem
PACKAGE RIPPED ABOUT HALFWAY DOWN THE PACKAGING, CAUSING THE NEEDLE TO BECOME UNSTERILE.