SECHRIST INDUSTRIES INC.

Additional Manufacturer Narrative

EU DISTRIBUTOR INFORMING SECHRIST OF MIXER HIGHLY CONTAMINATED WITH BLOOD AND CORROSION. NO PATIENT INVOLVEMENT OR INJURY REPORTED. NEITHER CUSTOMER NOR DISTRIBUTOR REPORTED TO FDA ACCORDING TO THE INFORMATION WE HAVE AT THIS TIME. DEVICE IN QUESTION WILL NOT BE EVALUATED BY SECHRIST AS EU DISTRIBUTOR WILL EVALUATE. EU DISTRIBUTOR CONFIRMED THE DEVICE WAS CONTAMINATED WITH BLOOD INTERNALLY AND CORROSION PRESENT AS WELL. AT THIS TIME, THE REPORT IS BASED ON THE INFORMATION WE HAVE RECEIVED FROM OUR EU DISTRIBUTOR. EU DISTRIBUTOR CONCLUDED THAT USER AND ERROR AND IMPROPER CLEANING OF DEVICE TO BE THE ROOT CAUSE. SECHRIST HAS INFORMED EU DISTRIBUTOR THAT ANY DEVICES THAT HAVE BEEN CONTAMINATED INTERNALLY WITH BLOOD OR CORROSION ARE TO BE DECOMISSIONED AND NOT SERVICED. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO: (B)(4).

Description of Event or Problem

EU DISTRIBUTOR INFORMING SECHRIST OF MIXER HIGHLY CONTAMINATED WITH BLOOD AND CORROSISON. NO PATIENT INVOLVEMENT OR INJURY REPORTED.