BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 7573529 · Received June 6, 2018

    Report

    Report Number
    1024879-2018-02180
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    October 31, 2017
    Report Date
    May 10, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903686525
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6245595; MEDICAL DEVICE EXPIRATION DATE: 08/31/2018; DEVICE MANUFACTURE DATE: 09/13/2016; MEDICAL DEVICE LOT #: 6257780; MEDICAL DEVICE EXPIRATION DATE: 09/30/2018; DEVICE MANUFACTURE DATE: 10/22/2016; MEDICAL DEVICE LOT #: 6160642; MEDICAL DEVICE EXPIRATION DATE: 05/31/2018; DEVICE MANUFACTURE DATE: 06/29/2016. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SETS WITH PRE-ATTACHED HOLDERS HAD CANNULAS SEALED IN THE SIDE OF THE PACKAGING, COMPROMISING STERILITY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417396 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 6293576 50382903686525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other