BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-PACK II

    MDR report key: 8089969 · Received November 20, 2018

    Report

    Report Number
    9681413-2018-00006
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    October 31, 2018
    Report Date
    November 20, 2018
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    FMI
    PMA / PMN Number
    K082820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO 1) CORRECT THE DATE THAT SUBMITTED IN THE INITIAL REPORT, THE CORRECT DATE IS (B)(6) 2018, 2) IT WAS INITIALLY REPORTED THAT THE DATE OF EVENT WAS (B)(6) 2018, HOWEVER, IT HAS NOW BEEN REPORTED THAT THE DATE OF EVENT IS UNKNOWN. THE REPORTED EVENT OCCURRED IN (B)(6) 2018, AND 3) PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE AWARE DATE FOR THE ADDITIONAL INFORMATION PROVIDED IS 11/20/18. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. DURING THE PACKAGING PROCESS, 40 PIECES ARE VISUALLY INSPECTED APPROXIMATELY EVERY FOUR HOURS FOR DAMAGES, DURING THE PACKAGING PROCESS, NO DAMAGED PRODUCTS WERE FOUND. AS AN IN-PROCESS CONTROL ON THE NEEDLE ASSEMBLY LINE, 40 PIECES ARE VISUALLY INSPECTED APPROXIMATELY EVERY FOUR HOURS FOR DAMAGED NEEDLE POINTS. NONE WERE FOUND. ALL REMAINING RETENTION SAMPLES WERE VISUALLY INSPECTED, NO DAMAGE WAS FOUND THAT COULD IMPACT THE STERILITY OF THE PRODUCT. AS PART OF THE FINAL INSPECTION BEFORE, MORE THAN 1,250 PIECES ARE VISUALLY INSPECTED FOR DAMAGES AND NONE WERE FOUND. BASED ON THE BATCH RECORD REVIEW AND THE INVESTIGATION ON THE RETENTION SAMPLES, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE - PATIENT GREATER THAN 60 YEARS OLD. DATE OF BIRTH - REQUESTED, NOT PROVIDED. SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE BATCH RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE QA IN-PROCESS INSPECTION FOR THE REPORTED LOT FOR THIS COMPLAINT REVEALED NO DEFECTS. ADDITIONALLY FINAL INSPECTION AFTER STERILIZATION REVEALED THAT THE COMPLAINT LOT MET MANUFACTURER SPECIFICATION, HENCE RELEASED TO THE MARKET. THE PRODUCT WAS STERILIZED BY A VALIDATED STERILIZATION CYCLE AND CONFIRMED BY LAL TEST. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO EUROPE N.V. (MANUFACTURER) REGISTRATION NO. 9681413 . EXEMPTION NUMBER E2015027.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE DURING A PARALLEL RUNNING CLINICAL STUDY, WITHIN A FEW HOURS AFTER APPLYING THE NEEDLE IN THE EYE, AN INFLAMMATION WAS OBSERVED AND HAZINESS WAS REPORTED WHICH DISAPPEARED AFTERWARDS. THE REPORTED EVENT WAS CONFIRMED TO BE STERILE NONINFECTIOUS. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 15, 2018. INVOLVED DRUG WAS APL2. THE INJECTION ITSELF WAS FINISHED WITHOUT DIFFICULTIES. THE DOSE WAS DELIVERED TO FULL EXTENT ON TREATMENT DATE. FURTHER TREATMENT IN ACCORDANCE WITH PROTOCOL IS SUSPENDED, PENDING THE OUTCOME OF THE BROAD SCOPE INVESTIGATION. THE PATIENT'S SYMPTOMS HAVE RESOLVED. PROPHYLACTICS WAS GIVEN TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED WITH NO ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929006 K-PACK II NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO EUROPE N.V N/A 1409007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention APL2| SYRINGE AND VIAL ADAPTOR| APL2| SYRINGE AND VIAL ADAPTOR