BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SAFE-CLIP

    MDR report key: 8476005 · Received April 2, 2019

    Report

    Report Number
    2243072-2019-00643
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 25, 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT ARE (B)(4). THESE SITE ARE AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE ON LOT # 5265381. 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: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SAFE-CLIP COULD NOT RECEIVE NEEDLES INTO ITS CONTAINER DESPITE THE CONTAINER WAS NOT FULL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿DEVICE ¿FROZE UP.¿ IT CANNOT RECEIVE NEEDLES INTO THE CLIPPING HOLE, THOUGH THE DEVICE IS NOWHERE NEAR ¿FULL¿ (AS THOUGHT THE HOLE BECAME MISALIGNED).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265246 BD¿ SAFE-CLIP SHARPS DISPOSAL FMI BECTON DICKINSON 5265381 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other