FILTER RETENTION PLATE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT, THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. 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. CONCLUSION AND MEASURES/PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION, FOR A MATERIAL MANUFACTURING OR DESIGN RELATED FAILURE. IN THE EVENT, THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS, A CAPA IS NOT NECESSARY.

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

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JK100 -FILTER RETENTION PLATE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REPORTED INCIDENT WAS AGAINST CATALOG ITEM # JK100 FOR THE FOLLOWING, AS STATED BY THE SUBMISSION FORM: "SURGERY FOUND SHAVINGS OF BLACK PLASTIC IN THEIR STERILE SET. IT WAS FOUND ON FILTER ON BOTTOM OF PAN. THEY BELIEVE IT'S FROM PLASTIC OF RETENTION PLATE. THEY DON'T HAVE THE PLATE TO RETURN FOR INVESTIGATION. NO CASE DELAY OR PATIENT HARM. THEY ENDED UP NOT EVEN USING THIS SET, AND USED AN ALTERNATIVE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).