FILTER RETENTION PLATE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: VISUAL INSPECTION: THE CORRESPONDING CONTAINER LID WAS NOT SUPPLIED. AT FIRST GLANCE THERE ARE NO SIGNS OF DAMAGE, ONLY SIGNS OF USE. THERE ARE NO SIGNS OF ABRASION ON THE FILTER HOLDER, SO IT CANNOT BE CONFIRMED THAT THE RESIDUE SUPPLIED IS FROM THE JK100 FILTER HOLDER. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THREE MEANINGFUL ATTEMPTS WERE MADE, AND NO FURTHER INFORMATION WAS PROVIDED. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: MW5118703. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: - NO DEATH OR SERIOUS INJURY. - NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THE REPORTING DECISION IS BASED UPON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. THE REVIEW OF THE RISK ANALYSIS REVEALED THAT THE APPLICABLE FAILURE MODE IS RATED WITH A SEVERITY OF 2(5). BASED UPON RISK MANAGEMENT REVIEW, IT IS CONCLUDED THAT EVEN IF THE REPORTED FAILURE IS TO REOCCUR, NO SERIOUS INJURY FOR PATIENT, USER OR THIRD PARTY IS TO BE EXPECTED. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THE REPORTED FAILURE OR DEVIATION COULD NOT BE CONFIRMED. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

THIS REPORT IS SUBMITTED IN REFERENCE TO THE MW5118703. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT JK100 - FILTER RETENTION PLATE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BLACK FLECKS PHYSICALLY MANIFEST THEMSELVES IN TWO AREAS PER CUSTOMER. IN ONE CASE, THE FLAKES MANIFESTED UNDER THE BASKET WHERE THE FILTERS WERE STORED. IN THE SECOND CASE, THEY MANIFESTED IN THE BOTTOM OF THE CONTAINERS THAT MAKE US OF THE RETENTION PLATE. THE BLACK FLECKS AND RETENTION PLATES WERE SENT TO AN INDEPENDENT LABORATORY FOR IDENTIFICATION AND ANALYSIS. IT WAS SHOWN THAT THE BLACK FLECKS ARE PLASTIC PARTICLES. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).