BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 8629214 · Received May 21, 2019

    Report

    Report Number
    2243072-2019-00975
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 11, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (2) BD BLUE/BLACK SAFE-CLIP (USED); ONE FROM LOT # 7205539, AND ONE FROM LOT # 7222543. CONSUMER REPORTED 2 PRODUCT ITEM # 328235 LOT # 7205539 USING WITH LANCETS; CURRENTLY KNOWS NOT TO USE WITH LANCETS ONLY PEN NEEDLES. ALSO REPORTED 7222543 NOT CLIPPING PEN NEEDLES 31G. BOTH RETURNED SAMPLES WERE EXAMINED AND THE CUTTER HOLES FOR BOTH APPEARED TO BE BLOCKED BY CANNULA CUT FROM PREVIOUS USAGE. CANNULA WERE NOT ABLE TO BE CUT USING EITHER RETURNED SAMPLE. SINCE THE CUSTOMER REPORTED THAT SAFE CLIP DEVICES WERE USED FOR CUTTING LANCETS, THE LIKELY SCENARIO IS THAT THE CUT LANCETS CAUSED DAMAGE TO THE SAFE CLIP CUTTER BLADES. THE SAFE CLIP WAS NOT INTENDED TO BE USED FOR LANCETS (AS PER IFU), THEREFORE THIS IS A USER ERROR. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. THE CUSTOMER REPORTED THAT THE RETURNED SAFE CLIP DEVICES WERE USED TO CUT LANCETS, WHICH IS NOT WHAT THE DEVICE WAS INTENDED TO BE USED FOR (AS PER IFU). THE LIKELY SCENARIO IS THAT THE CUT LANCETS CAUSED DAMAGE TO THE SAFE CLIP CUTTER BLADE, WHICH WOULD THEN LEAD TO THE INABILITY TO CUT ADDITIONAL CANNULAS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE NEEDLE CLIPPING DEVICE SAFE CLIP FROM LOT # 7205539 WAS BEING USED ON LANCETS, AND ONE SAFECLIP FROM LOT # 7222543 FAILED TO CLIP 31G PEN NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOT # 7205539 USING WITH LANCETS. CURRENTLY KNOWS NOT TO USE WITH LANCETS ONLY PEN NEEDLES 7222543 NOT CLIPPING PEN NEEDLES 31G."

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7205539, DEVICE MANUFACTURE DATE: 2017-08-24. MEDICAL DEVICE LOT #: 7222543, DEVICE MANUFACTURE DATE: 2017-09-09. DEVICE EVALUATED BY MFR: 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 ONE NEEDLE CLIPPING DEVICE SAFE CLIP FROM LOT # 7205539 WAS BEING USED ON LANCETS, AND ONE SAFECLIP FROM LOT # 7222543 FAILED TO CLIP 31G PEN NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOT # 7205539 USING WITH LANCETS. CURRENTLY KNOWS NOT TO USE WITH LANCETS ONLY PEN NEEDLES 7222543 NOT CLIPPING PEN NEEDLES 31G."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423724 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE CLIPPING DEVICE FMI BECTON DICKINSON SEE SECTION H.10. 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other