BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31X8 100 PK GERMANY

    MDR report key: 8465084 · Received March 29, 2019

    Report

    Report Number
    9616656-2019-00288
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    February 28, 2019
    Report Date
    April 12, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPENED 31G X 8MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 8122822, CAT. NO. 325105. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A CANNULA THROUGH SHIELD AND COVER WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA 131809 WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PN 31X8 100 PK GERMANY EXPERIENCED STERILITY BREACH. THE CUSTOMER STATED, "NEEDLE THROUGH OUTER AND INNER SHIELD".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PN 31X8 100 PK GERMANY EXPERIENCED STERILITY BREACH. THE CUSTOMER STATED, "NEEDLE THROUGH OUTER AND INNER SHIELD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260340 PN 31X8 100 PK GERMANY PEN NEEDLE FMI BECTON DICKINSON AND CO. 8122822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other