MalfunctionDWO
OSTEO-SITE BONE BIOPSY NEEDLE SET
Received Dec 14, 2018 · Event occurred Dec 5, 2016
Report 1820334-2018-03719 · MDR key 8165346
Device
Product problems
- Contamination /Decontamination Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO THE PATIENT CONTACT, DROPLET WAS FOUND INSIDE THE STERILE PACKAGE. IT WAS FURTHER NOTED THAT THE DEVICE PACKAGE HAD DROPLETS WHICH MAY INDICATE COMPROMISED STERILITY.