BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 8582319 · Received May 6, 2019

    Report

    Report Number
    2243072-2019-00857
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 19, 2019
    Report Date
    May 20, 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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (2) BD BLUE/BLACK SAFE-CLIPS FROM LOT # 8085005. CUSTOMER STATES THAT THE SAFE CLIP HAS STOPPED CLIPPING. RETURNED SAFE CLIP WAS EXAMINED UNDER MICROSCOPE AND OBSERVED TO HAVE THE CUTTING HOLE BLOCKED WITH NEEDLES. NEEDLES WERE NOT ABLE TO BE CUT USING THE RECEIVED 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. AT THIS POINT THE USER SHOULD DISPOSE THE SAFE CLIP CORRECTLY AS HE OR SHE WOULD FOR ANY FULL SHARPS COLLECTOR/CONTAINER. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP JAMMED AND WOULDN'T CLIP THE NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARENT OF CONSUMER REPORTING SAFE CLIP NOT CLIPPING NEEDLES. STATED THERE IS NO HOLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP JAMMED AND WOULDN'T CLIP THE NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARENT OF CONSUMER REPORTING SAFE CLIP NOT CLIPPING NEEDLES. STATED THERE IS NO HOLE."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). 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 CLIPPING DEVICE SAFE CLIP JAMMED AND WOULDN'T CLIP THE NEEDLES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARENT OF CONSUMER REPORTING SAFE CLIP NOT CLIPPING NEEDLES. STATED THERE IS NO HOLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378222 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8085005 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other