MalfunctionGDY
VISTEC
Received Apr 29, 2026
Report 1423537-2026-00127 · MDR key 25035135
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7318Catalog number
7318
Lot number
25L018362
Product problems
- Component Missing
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT UPON OPENING THE PACKAGE OF X-RAY DETECTABLE SPONGES, THERE WERE 12 SPONGES IN THE PACKAGE INSTEAD OF 10.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.