CYLINDRICAL SPONGE

Additional Manufacturer Narrative

PER CUSTOMER INFORMATION NO PATIENT INJURY OCCURRED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. INVESTIGATION: DUE TO THE PRODUCT NOT BEING RETURNED BY THE CUSTOMER, NO INSPECTION WAS PERFORMED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN FILED AND SENT TO THE SUPPLIER (GD MEDICAL) TO BE COMPLETED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

RADIOPAQUE COTTONWOOD SPONGE DID NOT SHOW UP ON X-RAY.

Additional Manufacturer Narrative

INVESTIGATION FINDING: A TOTAL OF 436 UNITS HAVE BEEN SOLD FROM MARCH 2019 TO PRESENT WITH A SALES/COMPLAINT RATIO OF 0.002294, DURING THIS TIME THIS IS THE ONLY COMPLAINT FOR THIS PRODUCT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT AND COMPLETED BY THE SUPPLIER (GD MEDICAL). SUPPLIER'S RESPONSE TO THE X-RAY FILAMENTS USED IN THE DEVICE WAS VERIFIED TO BE EFFECTIVE. ROOT CAUSE: AN ISOLATED HUMAN ERROR DURING THE MANUFACTURING PROCESS COULD BE A POTENTIAL ROOT CAUSE. CORRECTIVE ACTION: SUPERVISOR OVER THE SPONGE PRODUCTION WORKSHOP IS NOTIFIED OF THE INCIDENT. QUALITY ASSURANCE WILL PAY CLOSER ATTENTION TO THE ISSUE DURING IN-PROCESS AND FINISHED PRODUCT INSPECTIONS TO AVOID OCCURENCE. PREVENTIVE ACTION: WHEN RECEIVING RAW X-RAY FILAMENTS MATERIAL, X-RAY TESTING WILL BE CONDUCTED TO ENSURE EFFECTIVENESS. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.