MEDLINE
Received Apr 14, 2026 · Event occurred Mar 25, 2026
Report 1417592-2026-00433 · MDR key 24876545
Device
Generic name
Needle, Quincke, 22gx5" (div29)
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN8023
Lot number
25LBH112
Product problems
- Difficult to Open or Remove Packaging Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDED INFORMATION TO H6 (B) INVESTIGATION TYPE: 3331, 4121, 4110, AND 4111, BUT NO CHANGE TO INVESTIGATION FINDINGS OR CONCLUSION.
Additional Manufacturer Narrative
ON (B)(6) 2026, 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, AND NO DEATH, INJURY, FOLLOW-UP CARE, MEDICAL, AND/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.