MalfunctionGDY
VISTEC
Received Mar 5, 2025
Report 1423537-2025-00115 · MDR key 21529575
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health, Inc.Model number
7318Catalog number
7318
Lot number
24H081962
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE RAYTECHS ARE FALLING APART, SINGLE STERILE AND IN THE PACK.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Additional Manufacturer Narrative
A PHOTO SAMPLE WAS RECEIVED FOR THE INVESTIGATION. UPON A VISUAL EVALUATION OF THE PHOTO SAMPLE, THE REPORTED EVENT WAS CONFIRMED; THE GAUZE APPEARS TO HAVE BEEN UNRAVELED DURING THE PROCEDURE EXPOSING THE SALVAGE EDGE. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME.