PEANUT SPONGE

Additional Manufacturer Narrative

ROOT CAUSE: BASED ON THE RETURNED SAMPLE AND INVENTORY EVALUATION, THE ROOT CAUSE HAS BEEN IDENTIFIED AS A RAW MATERIAL DEFECT. THE RAW MATERIAL VENDOR, (B)(4), HAS BEEN ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED, "THE WORKERS MAY NOT FULLY MASTER THE OPERATION PROCEDURE AND THE QUALITY STANDARD. THEY DIDN'T WIND THE PEANUT SPONGE (TIGHTLY ENOUGH), SO THAT THE X-RAY ELEMENTS ARE LOOSE INSIDE THE SPONGE AND (HAVE) RISK OF EXPOSURE AND COMING OUT." AS SUCH, STAFF WAS RETRAINED ON THE OPERATION PROCEDURE AND QUALITY STANDARD TO ENSURE THEY FULLY MASTER ALL REQUIREMENTS CONCERNING PRODUCT. INVESTIGATION SUMMARY AN INTERNAL (B)(4) WAS RECEIVED INDICATING THAT A PEANUT SPONGE (FINISHED GOOD (B)(4)) CONTAINED A RADIOPAQUE THREAD THAT BECAME DETACHED FROM THE SPONGE. THE SURGEON PULLED THE INDIVIDUAL RADIOPAQUE THREAD FROM THE SURGICAL WOUND. A SAMPLE WAS RETURNED AND EVALUATED. ADDITIONALLY, AN INVENTORY EVALUATION WAS PERFORMED AND SHOWED THAT THE SPONGES WERE ROLLED LOOSER THAN THE APPROVED SAMPLE, ALLOWING FOR THE RADIOPAQUE THREAD TO BECOME LOOSE AND DETACHABLE FROM THE SPONGE. (B)(4). PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

THE RADIOPAQUE THREAD LODGED IN THE PEANUT SPONGE BECAME DETACHED. THE SURGEON PULLED AN INDIVIDUAL RADIOPAQUE THREAD OUT OF A SURGICAL WOUND. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE INCIDENT; HOWEVER, IF THE TEAM HAD NOT IDENTIFIED THE ISSUE, IT MAY HAVE LEAD TO AN INCIDENT.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A PEANUT SPONGE (FINISHED GOOD (B)(4)) CONTAINED A RADIOPAQUE THREAD THAT BECAME DETACHED FROM THE SPONGE. THE SURGEON PULLED THE INDIVIDUAL RADIOPAQUE THREAD FROM THE SURGICAL WOUND. THE CUSTOMER REPORTED A SAMPLE WAS AVAILABLE. HOWEVER, THE MANUFACTURING FACILITY HAS NOT RECEIVED THE SAMPLE AS OF THE DATE OF THIS REPORT. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED. (B)(4). COMPLAINT HISTORY FOR THE FINISHED GOOD NUMBER WAS REVIEWED FOR THE TIME PERIOD OF 2014-PRESENT. PRIOR TO THE REPORTING CUSTOMER FILING (B)(4), THERE WERE NO REPORTS OF THE RADIOPAQUE THREAD BECOMING DISLODGED FROM THE SPONGE. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

THE RADIOPAQUE THREAD LODGED IN THE PEANUT SPONGE BECAME DETACHED. THE SURGEON PULLED AN INDIVIDUAL RADIOPAQUE THREAD OUT OF A SURGICAL WOUND. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE INCIDENT; HOWEVER, IF THE TEAM HAD NOT IDENTIFIED THE ISSUE, IT MAY HAVE LEAD TO AN INCIDENT.