BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD A-LINE¿

    MDR report key: 19425249 · Received May 30, 2024

    Report

    Report Number
    9617032-2024-00831
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 10, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: "MATERIAL #: 364356. LOT/BATCH #: 3151661. BD RECEIVED 1 SAMPLE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR MISSING CASE LABEL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, A RETENTION CASE FROM BD INVENTORY WAS EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING CASE LABEL WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING CASE LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED AN OUTER BOX OF BD A-LINE¿ SYRINGES WAS MISSING ITS CASE LABEL. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150641 BD A-LINE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3151661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown