BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7274451 · Received February 15, 2018

    Report

    Report Number
    1920898-2018-00037
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 23, 2018
    Report Date
    April 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7030961. CUSTOMER RETURNED (1) LOOSE 3/10CC, 6MM SYRINGE. CUSTOMER STATES THAT THERE IS FOREIGN MATTER ON THE NEEDLE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED DARK FOREIGN MATERIAL ON THE CANNULA SHAFT. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF ADHESIVE. CAPA 91661 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS ADHESIVE RUNOVER. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 16MAR2018 FOR FURTHER REVIEW. ON 20MAR2018, HOLDREGE RECEIVED ONE (1) LOOSE 0.3ML, 6MM SYRINGE FROM REPORTED BATCH# 7030961. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PROBABLE ROOT CAUSE IS LIKELY TO BE THAT ADHESIVE MADE ITS WAY ONTO THE RUBBER O-RING ON THE NEEDLE LINE, TRANSFERRING THIS ADHESIVE TO THE CANNULA DURING PRODUCTION. THE O-RING SERVES TO EXERCISE THE CANNULA WITHIN THE HUB TO SMOOTHLY DISTRIBUTE ADHESIVE, LATER TO BE CURED AND PERMANENTLY AFFIX THE CANNULA WITHIN THE HUB. WHEN ADHESIVE GETS ON THIS RING, SMALL AMOUNTS CAN BE TRANSFERRED DIRECTLY ONTO THE CANNULA AND MAKE IT THROUGH TO THE CONSUMER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7030961. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE RUNOVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE. CAPA 91661 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS SHIELD DIFFICULT TO REMOVE/ADHESIVE RUN-OVER AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7030961 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD ULTRA-FINE¿ INSULIN SYRINGE WAS FOUND WITH FOREIGN MATTER AS THE¿ CUSTOMER DESCRIBED A BLACK BALL WITH THE ASPECT OF RUBBER¿ ON THE NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117309 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7030961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other