BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    MDR report key: 14166644 · Received April 21, 2022

    Report

    Report Number
    1318360-2022-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 21, 2022
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FPA
    UDI-DI
    00659443000308
    PMA / PMN Number
    K211206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1318360-2022-00002_RMS22609_N.80137_CONTAMINATED NEEDLE BAG_SECOND OCCURRENCE IS BEING FILED FOR THE MARCH 23, 2022 OCCURRENCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    ON 23-MAR-2022, KORU MEDICAL WAS MADE AWARE THAT DURING INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN (B)(6), JAPAN AN INSECT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH. THE TEAM AT THE JAPANESE WAREHOUSE TESTED THE POUCH WITH THE DEBRIS INSIDE AND VERIFIED VIA HAND PRESSURE THAT THE BAG WAS IN FACT SEALED. SUBSEQUENTLY, THE JAPANESE WAREHOUSE CONDUCTED A 100% INSPECTION ON THE REMAINING INVENTORY FROM MODEL RMS22609/LOT N.80137. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN AN UNIDENTIFIED BLACK CONTAMINANT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER STATED LOT N.80137 CONTAINED 1000 POUCHES. OF THE 1000, 11 POUCHES WERE PROVIDED FOR CLINICAL USE ON STUDY SUBJECTS ON (B)(6) 2022. AT THIS TIME, THE REMAINING 989 BAGS FROM THE LOT ARE QUARANTINED IN THE CUSTOMER'S INVENTORY SYSTEM. A RETURN MATERIAL AUTHORIZATION WAS CREATED FOR RETURN OF THE 2 POUCHES TO KORU MEDICAL FOR FURTHER EVALUATION. THE PRODUCTS ARE PENDING RETURN TO KORU MEDICAL AT THIS TIME. KORU MEDICAL COMPLETED AN INITIAL INVESTIGATION OF THE REPORTED INCIDENT. A SUMMARY OF THE RESULTS IS AS FOLLOWS: THE NEEDLE SETS WERE SHIPPED TO JAPAN WITH THE INTENTION OF SUPPORTING A CLINICAL STUDY. THEY WERE NOT INTENDED FOR COMMERCIAL DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT N.80137 WAS PERFORMED AND NO NONCONFORMANCES OR ABERRANT CONDITIONS WERE NOTED. RETAIN SAMPLES FROM N.80137 WERE INSPECTED FOR PACKAGE INTEGRITY AND CONTAMINATION. NO DEFECTS WERE IDENTIFIED. HIGH-FLO NEEDLE SETS ARE MANUFACTURED AND SEALED INTO THEIR PRIMARY STERILE BARRIER PACKAGING IN A CONTROLLED ENVIRONMENT. ENVIRONMENTAL CONTROLS INCLUDING AIR AND SURFACE BIOBURDEN RESULTS FROM THE RELEVANT PERIOD, AND PEST CONTROL RECORDS FROM THE PERIOD WERE REVIEWED AND NO NONCONFORMANCES WERE IDENTIFIED. A COMPLAINT REVIEW FROM 2017 TO PRESENT WAS PERFORMED AND CONFIRMED THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED FOR EVENTS OF THIS NATURE. HIGH-FLO NEEDLE SETS ARE STERILIZED USING GAMMA IRRADIATION WHICH IS A HIGHLY PENETRATING AND EFFECTIVE STERILIZATION MODALITY. FURTHERMORE, VALIDATION OF THE STERILIZATION METHOD WAS PERFORMED USING A CONSERVATIVE METHOD (VDMAX25) WHICH PROVIDES A SAFETY MARGIN OVER ALTERNATE ACCEPTABLE VALIDATION METHODS. A PRELIMINARY RISK ASSESSMENT WAS CONDUCTED TAKING INTO CONSIDERATION INFORMATION OBTAINED ON THE INCIDENT AND THE CURRENT RISK MANAGEMENT FILE. THE RESULTS OF THE ASSESSMENT CONCLUDED THAT THE CLINICAL RISK LEVEL REMAIN ACCEPTABLE. BASED UPON THE RESULTS OF THE INITIAL INVESTIGATION, KORU MEDICAL CONCLUDED THAT THE ISSUE EXPERIENCED IS NOT SYSTEMIC AND DOES NOT POSE AN UNACCEPTABLE HEALTH HAZARD. FURTHERMORE, A CORRECTIVE ACTION WAS INITIATED TO FURTHER INVESTIGATE. KORU MEDICAL COMMUNICATED THE RESULTS OF THE INITIAL INVESTIGATION TO THE CUSTOMER AND RECOMMENDED RELEASE OF ALL DEVICES THAT HAVE UNDERGONE THE 100% INSPECTION AND ANY ADDITIONAL DEVICES IN THE CUSTOMER'S INVENTORY MAY BE INSPECTED AND RELEASED FOR USE IN THE SAME MANNER. A HEALTH HAZARD EVALUATION ASSESSMENT WAS PERFORMED BY KORU MEDICAL WHICH DETERMINED THAT RISK OF PATIENT INFECTION DUE TO DEBRIS FOUND WITHIN THE STERILE NEEDLE POUCH IS ACCEPTABLE. THE INSTRUCTIONS FOR USE FOR THE HIGH-FLO NEEDLE SETS STATES "SUBCUTANEOUS NEEDLE SETS ARE ONLY STERILE AND NON-PYROGENIC IF THE PACKAGING IS UNOPENED AND UNDAMAGED. DO NOT USE A NEEDLE SET FROM AN OPEN OR DAMAGED PACKAGE." THE IFU FURTHER INSTRUCTS THE USER TO VISUALLY INSPECT TUBING AND NEEDLE SETS PRIOR TO USE. REITERATES NOT TO USE IF THE POUCH IS COMPROMISED. KORU MEDICAL WILL CONTINUE THE INVESTIGATION FOLLOWING RECEIPT OF THE DEFECTIVE PRODUCTS FROM THE CUSTOMER. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772004 REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS FPA REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS RMS22609 N.80137 00659443000308

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown