BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD COLLECTION SET WITH LUER ADAPTER

    MDR report key: 7533775 · Received May 22, 2018

    Report

    Report Number
    2243072-2018-00778
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    July 14, 2016
    Report Date
    June 8, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE: THIS HAS BEEN CORRECTED TO "JKA". PMA / 510(K)#: THIS HAS BEEN CORRECTED TO "K991088".

    Additional Manufacturer Narrative · 1

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5G287, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 10/07/2005. MEDICAL DEVICE LOT #: 5D231, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 06/16/2005. PMA/510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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® BLOOD COLLECTION SETS WITH LUER ADAPTERS HAD NO EXPIRATION DATE ON THE BOX. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377711 BD VACUTAINER® BLOOD COLLECTION SET WITH LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 5C131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other