TERUMO INJECTION FILTER NEEDLE

Additional Manufacturer Narrative

D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: DEVICE QUALITY MANAGER. H6: INVESTIGATION FINDINGS: CODE 3221 IS BASED UPON NO SAMPLE RETURNED; CODE 213 IS BASED UPON FUNCTIONAL TESTING OF THE RETENTION SAMPLE. H6 - INVESTIGATION CONCLUSION: CODE 4315 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND NO DEVICE RETURN; CODE 67 IS BASED UPON EVALUATION OF THE RETENTION SAMPLE. THE BATCH RECORDS FOR LOT 2409011 (NF3013RBKE05M) HAVE BEEN REVIEWED. NO ANOMALY WAS FOUND. THE FOLLOWING TESTS ARE PERFORMED ON THE PRODUCT DURING PRODUCTION: DURING IN-PROCESS CONTROL IN NEEDLE ASSEMBLY, 315 NEEDLES ARE VISUALLY INSPECTED PER SHIFT FOR FOREIGN MATTER. NO ABNORMALITIES RELATED TO THIS COMPLAINT WERE REPORTED DURING THESE INSPECTIONS. DURING IN-PROCESS CONTROL IN PACKAGING, 40 NEEDLES ARE VISUALLY INSPECTED TWICE PER SHIFT FOR FOREIGN MATTERS. NO ABNORMALITIES RELATED TO THIS COMPLAINT WERE REPORTED DURING THESE INSPECTIONS. FURTHERMORE, A FINAL VISUAL INSPECTION WAS PERFORMED ON 1500 PIECES. NO ABNORMALITIES RELATED TO THIS COMPLAINT WERE REPORTED DURING THESE INSPECTIONS. AS PART OF THE FINAL INSPECTION, PARTICULATE MATTER IS TESTED ON 84 PIECES AND A VISUAL INSPECTION ON 13 PIECES. THIS WAS CONFORMING TO THE SPECIFICATION. THE LAL AND STERILIZATION CYCLE WERE EXECUTED ACCORDING TO SPECIFICATION, AND NO OBSERVATIONS HAVE BEEN FOUND FOR THESE TESTS. BASED ON OUR INVESTIGATION, NO ROOT CAUSE RELATED TO OUR PRODUCTION PROCESS HAS BEEN FOUND. THERE IS NO OUT OF TREND FOUND AND THERE IS NO CHANGE IN THE BENEFIT-RISK DETERMINATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO EUROPE N.V. (MANUFACTURER) REGISTRATION NO. 9681413.

Description of Event or Problem

TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT RECEIVED VABYSMO INJECTIONS IN BOTH EYES AND SUBSEQUENTLY DEVELOPED BILATERAL UVEITIS IN BOTH EYES. THE DOCTOR HAD A LOT OF EXPERIENCE WITH THIS PRODUCT, AND IT WAS THE FIRST TIME HE ENCOUNTERED SOMETHING LIKE THIS. THE PHARMACIST CONFIRMED THAT THE PRODUCT USED WAS STORED AT A TEMPERATURE OF 2-8°C. THERE WERE NO TEMPERATURE DEVIATIONS. THE FINAL PATIENT IMPACT WAS UNKNOWN.