BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7096520 · Received December 7, 2017

    Report

    Report Number
    1024879-2017-00560
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    December 6, 2016
    Report Date
    February 28, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673421
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR 276448 WAS FILED TO CORRECT THE DATE OF AWARENESS REFERENCED IN CAPA 163116. THE SUPPLEMENTAL MDR REFLECTED THE DATES GIVEN TO BD BY THE CUSTOMER. THOSE DATES WERE REPORTED INCORRECTLY. INITIAL MDR GIVES THE DATE OF EVENT AS (B)(6) 2016. THE INITIAL MDR WAS CORRECT. INITIAL MDR GIVES THE DATE RECEIVED BY MANUFACTURER AS 12/20/2016. THE CORRECT DATE RECEIVED BY MANUFACTURER IS 12/08/2016.

    Additional Manufacturer Narrative · 1

    INITIAL MDR GIVES THE DATE OF EVENT AS (B)(6) 2016. THE CORRECT DATE OF EVENT IS (B)(6) 2016. INITIAL MDR GIVES THE DATE RECEIVED BY MANUFACTURER AS 12/20/2016. THE CORRECT DATE RECEIVED BY MANUFACTURER IS 08/12/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET LEAKED OUT OF THE TUBING AFTER USE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877716 BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 00382903673421

    Patients

    Seq Age Sex Outcome Treatment
    1 Other