BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 9831720 · Received March 13, 2020

    Report

    Report Number
    3003152976-2020-00130
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 23, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT VARIABLE INFORMATION, LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE, ARE MISSING FROM THE BLISTER PACKAGING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1911729, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS RELATED TO THE REPORTED ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE NO DIRECT ISSUES WERE IDENTIFIED, A WORK ORDER WAS FOUND REGARDING A PRINTER FAILURE FOR THE PACKAGING MACHINE WHICH WAS REPLACED. BASED ON OUR QUALITY TEAM'S INVESTIGATION, IT WAS DETERMINED THIS INCIDENT WAS LIKELY RELATED TO THAT EQUIPMENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE BLISTER PACK WAS FOUND WITH NO CHARGE OR EXPIRATION DATE ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "ON MANY OF THE BLISTER PACKS THERE IS NO CHARGE AND EXPIRATION DATE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE, THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE BLISTER PACK WAS FOUND WITH NO CHARGE OR EXPIRATION DATE ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON MANY OF THE BLISTER PACKS THERE IS NO CHARGE AND EXPIRATION DATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295809 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1911729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other