BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE LIHEP PLH 13X100 6.0 PLBLCE GN

    MDR report key: 9593873 · Received January 15, 2020

    Report

    Report Number
    9617032-2020-00012
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 31, 2019
    Report Date
    February 3, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBE LIHEP PLH 13X100 6.0 PLBLCE GN DID NOT HAVE "EITHER LABEL" ON IT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBE DIDN'T HAVE EITHER LABEL ON IT."

    Additional Manufacturer Narrative · 1

    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 TUBE LIHEP PLH 13X100 6.0 PLBLCE GN DID NOT HAVE "EITHER LABEL" ON IT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBE DIDN'T HAVE EITHER LABEL ON IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57251 TUBE LIHEP PLH 13X100 6.0 PLBLCE GN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9235325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other