7318 SPG VISTEC 8 X 4 STR 10 S
Received Dec 3, 2024 · Event occurred Nov 14, 2024
Report 1423537-2024-00329 · MDR key 20836157
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health, Inc.Model number
7318Catalog number
7318
Lot number
24HO81962
Product problems
- Material Frayed
- Material Frayed
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. A SAMPLE WAS RETURNED AND UPON A VISUAL EVALUATION, THE REPORTED ISSUE WAS OBSERVED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.
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 VISTEC GAUZE IS FRAYING.