COTTON BALL

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING A COTTON BALL WITH AN X-RAY DETECTABLE ELEMENT FAILED TO APPEAR ON AN X-RAY. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE INITIAL REPORTER DID NOT PROVIDE A LOT NUMBER. THE COTTON BALL IS SUPPLIED TO DEROYAL BY GD MEDICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO GD MEDICAL ON APRIL 17, 2017. A RESPONSE IS DUE MAY 26, 2017. AS OF THE DATE OF THIS REPORT, THE RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

THE PRODUCT IS SUPPOSED TO BE X-RAY DETECTABLE. HOWEVER, AFTER SURGERY, THE NURSES COUNTED THE COTTON BALLS AND DISCOVERED THAT THEY WERE SHORT BY ONE. THEY X-RAYED THE PATIENT AND THE COTTON BALL DID NOT SHOW UP. THEY X-RAYED SOME OF THE OTHER COTTON BALLS THEY HAD LEFT AND THOSE DID NOT SHOW UP. THE X-RAY ELEMENT DID NOT SHOW UP.THE COTTON BALLS WERE USED DURING SURGERY ON THE PATIENT'S HEAD TO REMOVE A TUMOR.

Additional Manufacturer Narrative

ROOT CAUSE: THE COTTON BALL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN ITS SCAR RESPONSE, (B)(4) STATED IT WAS UNABLE TO IDENTIFY A ROOT CAUSE WITHOUT A REPORTED LOT NUMBER FROM THE CUSTOMER. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING A COTTON BALL WITH AN X-RAY DETECTABLE ELEMENT FAILED TO APPEAR ON AN X-RAY. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE INITIAL REPORTER DID NOT PROVIDE A LOT NUMBER. THE COMPLAINT INVESTIGATOR MADE ATTEMPTS ON MAY 2, MAY 12, AND JUNE 2 TO RETRIEVE A SAMPLE FROM THE REPORTING CUSTOMER. WITHOUT A LOT NUMBER, WORK ORDER REVIEW COULD NOT BE COMPLETED. THE COMPLAINT INVESTIGATOR CHECKED AVAILABLE RAW MATERIAL ON HAND, AND ALL SAMPLES WERE FOUND TO BE ACCEPTABLE. THE COTTON BALL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO (B)(4) ON APRIL 17, 2017. A RESPONSE WAS RECEIVED JUNE 4, 2017. DEROYAL PERSONNEL REVIEWED AND ACCEPTED THE RESPONSE JUNE 5, 2017. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS FOR THE ITEM WERE IDENTIFIED. DEROYAL WILL CONTINUE TO MONITOR POST-MARKET FEEDBACK. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

THE PRODUCT IS SUPPOSED TO BE X-RAY DETECTABLE. HOWEVER, AFTER SURGERY, THE NURSES COUNTED THE COTTON BALLS AND DISCOVERED THAT THEY WERE SHORT BY ONE. THEY X-RAYED THE PATIENT AND THE COTTON BALL DID NOT SHOW UP. THEY X-RAYED SOME OF THE OTHER COTTON BALLS THEY HAD LEFT AND THOSE DID NOT SHOW UP. THE X-RAY ELEMENT DID NOT SHOW UP. THE COTTON BALLS WERE USED DURING SURGERY ON THE PATIENT'S HEAD TO REMOVE A TUMOR.