MalfunctionGDY
X RAY SPONGE
Received Apr 28, 2026 · Event occurred Apr 23, 2026
Report MW5187402 · MDR key 25019489
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Medical / Cardinal Health 200, LlcCatalog number
7317- 14TR
Lot number
25K047062
Patient
41 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CONCERN FOR X-RAY SPONGES FALLING APART AFTER USE INSIDE PATIENT'S VAGINA. BLUE X-RAY DETECTABLE [INVALID]NOTED TO BE FALLING OUT. CHARGE NURSE, NURSE MANAGER, AND SUPPLIES MADE AWARE. SURGEON AND RESIDENT AWARE. INTRA-OPERATIVE X-RAY COMPLETED PRIOR TO PATIENT LEAVING OR. PACKAGE AND LOT NUMBER SAVED FOR INVESTIGATION WITH MANUFACTURER.