BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7491206 · Received May 7, 2018

    Report

    Report Number
    9617032-2018-00882
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    July 6, 2017
    Report Date
    May 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE BRAND NAME: ORIGINAL ENTRY: BD PRESET¿ ECLIPSE¿. UPDATED ENTRY: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. UNIQUE IDENTIFIER (UDI) #: ORIGINAL ENTRY: (B)(4). UPDATED ENTRY: (B)(4). PMA / 510(K) #: ORIGINAL ENTRY: K022426. UPDATED ENTRY: BK050036.

    Additional Manufacturer Narrative · 1

    RETURNED TO MANUFACTURER ON: UNKNOWN. THE INVESTIGATION DATE HAS BEEN USED FOR THIS FIELD. (B)(6). BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR 107715 WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRESET¿ ECLIPSE¿ RUBBER STOPPERS REMAINED INSIDE AFTER OPENING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335576 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7079577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other