BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7431207 · Received April 13, 2018

    Report

    Report Number
    1920898-2018-00207
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 22, 2018
    Report Date
    May 11, 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 SUMMARY: CUSTOMER RETURNED ONE LOOSE 3/10CC SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DETACHED CANNULA. THE LOOSE CANNULA WAS RETURNED IN THE SHIELD. THE SAMPLE WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED LITTLE ADHESIVE IN THE HUB. THE LOOSE CANNULA WAS ALSO EXAMINED AND EXHIBITED ADHESIVE ON THE CANNULA SHAFT. 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 NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DETACHED CANNULA). PROBABLE ROOT CAUSE IS LIKELY TO BE A MISALIGNMENT OF THE ADHESIVE NOZZLE DURING CANNULATION ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE MAY BE EITHER OVER-DISPENSED OR MIS-DISPENSED, MISSING THE HUB ASSEMBLY ENTIRELY. THIS WOULD LEAD TO CANNULA SEPARATES AND EASIER CANNULA PULL OUTS BY THE CONSUMER. PRIOR WORK WITH CAPA (B)(4)TO ADDRESS SHIELD DIFFICULT TO REMOVE/ADHESIVE RUN-OVER AND ITS ASSOCIATED ROOT CAUSE(S) IDENTIFIED THE PRIMARY ROOT CAUSE FOR MISPLACEMENT OF ADHESIVE ON THE NEEDLE LINES. BATCH# 7030961 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA.

    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 THE NEEDLE SEPARATED ON A BD ULTRA-FINE¿ INSULIN SYRINGE AFTER INSERTING IT INTO THE INSULIN BOTTLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274126 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7030961

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other