MalfunctionGDY
SAFE-T LAPAROTOMY GAUZE SPONGE, X-RAY DETECTABLE, STERILE, MASTER-TAGGED, 18" X
Received May 21, 2025 · Event occurred Feb 14, 2025
Report 22059656 · MDR key 22059656
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker InstrumentsCatalog number
0611-018-180
Lot number
1332
Product problems
- Delivered as Unsterile Product
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
STRYKER SURGICOUNT LAPAROTOMY SPONGE INNER WRAPPER HAD HOLE IN IT. BREAK IN STERILE PACKAGING WAS IDENTIFIED BEFORE IT REACHED THE STERILE FIELD.