MalfunctionOXQ
KIT CAP CHANGE STERILE
Received Apr 14, 2025 · Event occurred Apr 7, 2025
Report MW5168981 · MDR key 21833829
Device
Product problems
- Device Contamination with Chemical or Other Material
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE PREPARING TO DO A CAP CHANGE, A CAP CHANGE TRAY WAS OPENED IN A STERILE MANOR. A HAIR WAS FOUND WITHIN THE PACKAGING. A NEW KIT WAS OBTAINED AND CAP CHANGE WAS COMPLETE. PACKAGE INFORMATION: GTIN: (B)(4); EXP (17) 2025-06-01; LOT (10) 6000625.