BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7098841 · Received December 7, 2017

    Report

    Report Number
    1024879-2017-00548
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    October 11, 2016
    Report Date
    January 26, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). RESULTS: BD RECEIVED 3 SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. SAMPLES WERE NOT EVALUATED. COMPLAINT WAS CONFIRMED DUE TO RELATED COMPLAINTS CONNECTED TO CAPA (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6131796. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE. CAPA (B)(4) HAS BEEN INITIATED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE OF EVENT. THE CORRECT DATE OF EVENT IS (B)(6) 2016. THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE RECEIVED BY MANUFACTURER. THE CORRECT DATE RECEIVED BY MANUFACTURER IS 10/21/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET, HAD LEAK AT ADAPTATION AND TUBING. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO MEDICAL INTERVENTION OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877241 BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6131796 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other