BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BRAND SSTÄ II TUBES CONTAINING SILICA AND GEL

    MDR report key: 7081047 · Received December 4, 2017

    Report

    Report Number
    9617032-2017-00200
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    April 14, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K023331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER. THE 510K OF THIS DEVICE IS K023331.

    Additional Manufacturer Narrative · 1

    RESULTS BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR A DAMAGED RUBBER STOPPER ON THE TUBE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: DUE TO THE SEVERITY AND FREQUENCY OF THE REPORTED CONDITION, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE INDICATED LOT # AND REPORTED CONDITION WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® BRAND SSTÄ II TUBES CONTAINING SILICA AND GEL HAD A DAMAGED RUBBER STOPPER ON THE TUBE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860853 BD VACUTAINER® BRAND SSTÄ II TUBES CONTAINING SILICA AND GEL BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 5146457

    Patients

    Seq Age Sex Outcome Treatment
    1 Other