VISTEC
Received Mar 5, 2025
Report 1423537-2025-00117 · MDR key 21529636
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health, Inc.Model number
7318Catalog number
7318
Lot number
23M059162
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE GAUZE IS FRAYING. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED AT THE PLANT FOR THE INVESTIGATION. UPON A VISUAL EVALUATION OF THE SAMPLE, THE REPORTED EVENT WAS CONFIRMED; THE SALVAGE EDGE WAS EXPOSED. A ROOT CAUSE ANALYSIS INDICATED THAT THIS OCCURRED DURING OUR MANUFACTURING PROCESS. A PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE.