MAGNET
Received Jan 30, 2024 · Event occurred Jan 2, 2024
Report 1000165971-2024-00080 · MDR key 18604568
Device
Generic name
Magnet, Test, Pacemaker
Manufacturer
Microport Crm S.r.l.Model number
MAGNETCatalog number
MAGNET
Lot number
M00008
Product problems
- Packaging Problem
- Packaging Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ANALYSIS SYNTHESIS: IT WAS REPORTED THAT ONE OF THE EXTERNAL LABELS ON TWO MAGNET PACKAGING BOXES WERE PLACED ON THE OPPOSITE SIDE TO THE USUAL ONE AND THAT THE MAGNETS WERE REVERSELY POSITIONED. REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED TO THE PACKAGING OPERATION OF THE SUBJECT DEVICE REVEALED THAT THE DEVICE WAS PACKAGED AND RELEASED FOLLOWING ALL APPLICABLE PROCEDURES. THE REPORTED DIFFERENCES IN THE POSITION OF THE MAGNET AND THE EXTERNAL LABEL ARE MOST LIKELY DUE TO HUMAN ERROR. OPERATORS WILL BE RETRAINED TO REDUCE THE RECURRENCE OF THIS KIND OF ISSUE.
Description of Event or Problem
REPORTEDLY, THE POSITION OF ONE OF THE EXTERNAL LABEL IS DIFFERENTLY PLACED THAN USUAL AND THE MAGNET POSITION INSIDE THE BOX IS ALSO DIFFERENT.