BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE

    MDR report key: 8185921 · Received December 20, 2018

    Report

    Report Number
    2243072-2018-01887
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 1, 2018
    Report Date
    December 20, 2018
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A SAFE CLIP. CUSTOMER STATES THAT THE CUTTER EITHER BECOMES BLUNT, OR IT RUSTS. A PHOTO WAS EXAMINED AND EXHIBITED MATERIAL SURROUNDING THE CUTTING HOLE OF THE SAFE CLIP. THE MOST LIKELY SCENARIO IS THAT THE SAFE CLIP IS FULL, IT HAS BEEN USED OVER TIME AND THERE IS NO MORE ROOM TO STORE ANY ADDITIONAL CANNULA. THIS USUALLY RESULTS AFTER NORMAL USE OF THE PRODUCT AND IS THEREFORE NOT CONFIRMED AS A DEFECT. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: THIS USUALLY RESULTS AFTER NORMAL USE OF THE PRODUCT. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE BECAME BLUNT OR RUSTED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023689 BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE NEEDLE CIPPING DEVICE FMI BECTON DICKINSON 5146363 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other