MalfunctionCAF
MCKESSON
Received May 12, 2026 · Event occurred Mar 13, 2026
Report 1417519-2026-00001 · MDR key 25153270
Device
Product problems
- Off-Label Use
- Contamination /Decontamination Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINT REPORTER; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE INVESTIGATION IS CURRENTLY ONGOING WITH NO RESPONSE TO ADDITIONAL INFORMATION REQUESTS.
Description of Event or Problem
PRODUCT CAUSING A BACTERIA ON CUSTOMERS, AND THE ITEM IS BEING USED DURING SURGERY.