BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 8344051 · Received February 15, 2019

    Report

    Report Number
    1213809-2019-00195
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 30, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ALTHOUGH NO SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION FOR THIS COMPLAINT, SIMILAR ISSUE WAS PREVIOUSLY INVESTIGATED : THE LABEL ON THE OUTSIDE OF THE CASE CARTON WAS CONFIRMED TO BE FROM BATCH# 8285697 AND TRAYS INSIDE THE CASE CARTON WERE LABELED AS INCORRECT BATCH# 8280697. THE BATCH NUMBER WAS INCORRECT ON THE TOP WEB AND NO REJECTIONS WERE NOTED DUE TO HUMAN ERROR DURING INSPECTION. QUALITY NOTIFICATION WAS LATER IDENTIFIED WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONAL INSPECTION PERFORMED AND THE BATCH WAS RELEASED BASED ON MEETING OUR RE-QUALIFICATION REQUIREMENT. ROOT CAUSE: SOFTWARE BUG WITH THE VARIABLE PRINTER AND DUE TO HUMAN ERROR DURING INSPECTIONS. PREVENTIVE AND CORRECTIVE ACTION, CAPA#900946 HAVE BEEN INITIATED TO INVESTIGATE THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOT NUMBER ON THE OUTER BOX OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY WAS DIFFERENT THAN THE ONE ON THE INNER PACKAGES.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR? 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 LOT NUMBER ON THE OUTER BOX OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY WAS DIFFERENT THAN THE ONE ON THE INNER PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139429 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8285697 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other