VISTEC
Received Mar 5, 2025 · Event occurred Feb 26, 2025
Report 1423537-2025-00118 · MDR key 21529683
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health, Inc.Model number
7318Catalog number
7318
Lot number
24G032362
Product problems
- Component Missing
- Component Missing
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 VISTEC SPONGE THAT ONLY HAD 9 SPONGES IN IT INSTEAD OF 10.
Additional Manufacturer Narrative
SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.