DR FOG TREATED SPONGE; STERILE

Description of Event or Problem

COMPLAINANT ALLEGES "STERILIZED FAILURE".

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT THE COMPLAINT WAS CONFIRMED BASED ON THE PICTURE THAT WAS PROVIDED. THE ROOT CAUSE WAS MANUFACTURING ERROR. THE SAMPLE CONTAINED A SPONGE WITHIN THE PACKAGE SEAL. THE MOST PROBABLE ROOT CAUSE IS RELATED TO MANUAL POUCH LOADING AND MOVEMENT OF THE FOAM DURING THE SEALING PROCESS. LIGHT WEIGHT SPONGE MATERIAL, MANUAL PLACEMENT OF FOAM INTO THE TRAY, AND A SHALLOW POUCH DESIGN MAY ALL CONTRIBUTE, AS WELL AS THE FOAM COLOR CLOSELY MATCHING THE TYVEK MATERIAL SO IT CAN BE DIFFICULT TO DETECT DURING MANUAL END-OF-LINE INSPECTION. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.