LAPAROTOMY SPONGE

Additional Manufacturer Narrative

AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING AN END USER WAS DISSATISFIED WITH THE QUALITY OF A LAPAROTOMY SPONGE (FINISHED GOOD 1-1818, LOT NUMBER 45545469). THE END USER REPORTED THE BLUE LOOP OF THE LAP SPONGE SEPARATED TOO EASILY FROM THE DEVICE AND THAT THE X-RAY DETECTABLE BARIUM STRIP WAS TOO SMALL TO BE DETECTED WHEN BUNDLED UP INSIDE THE PATIENT. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

END USER REPORTED THE BLUE LOOP RIPS OFF TOO EASILY AND THE BARIUM STRIP IS TOO SMALL. THE X-RAY MACHINE WILL NOT DETECT THE BARIUM STRIP IF IT IS BUNDLED UP INSIDE A PATIENT'S BODY.

Description of Event or Problem

END USER REPORTED THE BLUE LOOP RIPS OFF TOO EASILY AND THE BARIUM STRIP IS TOO SMALL. THE X-RAY MACHINE WILL NOT DETECT THE BARIUM STRIP IF IT IS BUNDLED UP INSIDE A PATIENT'S BODY.

Additional Manufacturer Narrative

ROOT CAUSE: THE LAPAROTOMY SPONGE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION RESPONSE (SCAR) WAS ISSUED TO (B)(4). IN ITS RESPONSE, (B)(4) STATED A ROOT CAUSE IS UNKNOWN. IN ITS INVESTIGATION, (B)(4) CHECKED ALL OF ITS SPONGES AND CONFIRMED THE X-RAY DETECTABLE ELEMENTS WERE PLACED DURING THE REGULAR SEWING OPERATION. THEY ALSO CONFIRMED THAT THESE ITEMS WERE SEWN BY THE DOUBLE CONTINUOUS SEAMS WITH WHICH THE SPONGE IS SEWN. ALL OF THE SPONGES HAD LOOPS FIRMLY PLACED. THE BARIUM STRIP SIZE ALSO WAS CHECKED, AND THE STRIPS MET THE SIZE SPECIFICATION (MINIMUM LENGTH 4.3 CM., MINIMUM WIDTH 1.2 CM). ADDITIONALLY, ALL BATCHES OF THE BARIUM STRIP ARE SAMPLED AT THE TIME OF RECEIPT, AND THE SAMPLES ARE SENT TO A RADIOLOGY LABORATORY FOR TESTING. ALL BATCHES HAVE SUCCESSFULLY PASSED THIS RADIOGRAPHY TEST. CORRECTIVE ACTION: IN ITS RESPONSE TO THE SCAR, (B)(4) IDENTIFIED THAT PREVIOUS ISSUES HAVE BEEN REPORTED OF THE X-RAY LOOP DETACHING FROM THE SPONGE. IN RESPONSE TO THIS ISSUE, (B)(4) IMPLEMENTED A DOUBLE SEAM ON THE SIDE OF THE SPONGE WHERE THE LOOP IS SEWN. THIS CORRECTIVE ACTION WAS PREVIOUSLY IMPLEMENTED WITH LOT NUMBER 09-17. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING AN END USER WAS DISSATISFIED WITH THE QUALITY OF A LAPAROTOMY SPONGE (FINISHED GOOD 1-1818, LOT NUMBER 45545469). THE END USER REPORTED THE BLUE LOOP OF THE LAP SPONGE SEPARATED TOO EASILY FROM THE DEVICE AND THAT THE X-RAY DETECTABLE BARIUM STRIP WAS TOO SMALL TO BE DETECTED WHEN BUNDLED UP INSIDE THE PATIENT. A SAMPLE WAS NOT AVAILABLE FOR RETURN. DUE TO THE ABSENCE OF A SAMPLE AND NO NON-CONFORMING PRODUCT FOUND AT DEROYAL'S MANUFACTURING FACILITY OR THE VENDOR'S, THE REPORTED DEFECT CANNOT BE CONFIRMED. RAW MATERIAL STOCK OF THE LAP SPONGE AT THE DEROYAL MANUFACTURING FACILITY WAS INSPECTED. THREE HUNDRED 'EACHES" WERE INSPECTED AND NO NON-CONFORMING PRODUCT WAS IDENTIFIED. A SCAR WAS ISSUED TO (B)(4) AND A RESPONSE HAS BEEN RECEIVED. (B)(4). PREVENTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) INDICATED IT PERFORMED AN INTERNAL AUDIT OF ITS MANUFACTURING PROCESS TO ENSURE THE DOUBLE SEAM LOOP IS STILL WORKING PROPERLY. THIS AUDIT WAS PERFORMED FEBRUARY 15, 2018, AND NO NON-CONFORMITIES WERE FOUND. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.