MalfunctionGDY
VISTEC
Received Jul 31, 2026 · Event occurred Jul 24, 2026
Report 1423537-2026-00251 · MDR key 50097874
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7320Catalog number
7320
Lot number
26C050762
Product problems
- Component Missing
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that some packages of sponges had only 9 each, instead of 10. On 30JUL2026 the initial reporter confirmed that their OR had the reported issue with one package. She audited two more packages of the same lot and did not find any more issues. This event occurred before patient use.
Additional Manufacturer Narrative
An investigation is currently underway. Upon completion, the results will be forwarded.