inforMED
MalfunctionGDY

SITUATE PREMIUM TAGGED COTTON RFD SURGICAL GAUZE

Received Aug 21, 2025 · Event occurred Jul 31, 2025

Report MW5175108 · MDR key 22871243

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Manufacturer

Medtronic, Inc.

Model number

G0804-12P02C-1

Lot number

241009AT

Product problems

  • Material Frayed
  • Device Damaged Prior to Use
  • Defective Device
  • Material Frayed
  • Device Damaged Prior to Use
  • Defective Device

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

(B)(6) RECEIVED A WARNING FROM THE FDA. (B)(6) ITEM MANAGER MR. (B)(6) REMOVED THE LOT NUMBER AFFECTED IN THE WARNING FROM THE SHELF AND PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE. THIS ITEM (RAYTECS) WAS FRAYING OFF; THEN WE PROCEEDED TO OPEN THREE MORE RAYTEC PACKAGES WHEN WE FOUND OUT THAT ALL OF THEM LOOKED ALIKE (FRAYING OFF) 4/4 OPENED. TO PREVENT ANY RISK TO OUR SURGICAL PATIENTS, WE QUARANTINE THE ENTIRE CASE UNTIL FURTHER GUIDELINES ARE PROVIDED. ALSO, OUR CUSTOMERS REFUSED TO USE SUCH AN ITEM TO PREVENT ANY PATIENT SAFETY ISSUES. DEVICE CODES: 1262, 2284, 2588. PATIENT CODE: 4582. REFERENCE REPORT MW5175107.