BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE LUER-LOK¿ TIP W/TIP SHIELD BULK NON-STERILE

    MDR report key: 7080650 · Received December 4, 2017

    Report

    Report Number
    1213809-2017-00319
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    October 31, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7121846. MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 05/01/2017. PRINTING ISSUE AND FOREIGN MATTER. MEDICAL DEVICE LOT #: 7250881. MEDICAL DEVICE EXPIRATION DATE: 08/31/2022. DEVICE MANUFACTURE DATE: 09/07/2017. PRINTING ISSUE. MEDICAL DEVICE LOT #: 6023786. MEDICAL DEVICE EXPIRATION DATE: 12/31/2020. DEVICE MANUFACTURE DATE: 01/23/2016. FOREIGN MATTER-BURNT PLASTIC AND FM INK. MEDICAL DEVICE LOT #: 7120885. MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 04/30/2017. FM DIRT/BURNT PLASTIC. MEDICAL DEVICE LOT #: 6056830. MEDICAL DEVICE EXPIRATION DATE: 02/28/2021. DEVICE MANUFACTURE DATE: 02/25/2016. FM INK. SCALE MARKING PROBLEM. MEDICAL DEVICE LOT #:7096778. MEDICAL DEVICE EXPIRATION DATE: 03/31/2022. DEVICE MANUFACTURE DATE: 04/06/2017. PHOTO ONLY SCALE MARKING PROBLEM. RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOTS WAS OBSERVED. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE REPORTED LOT NUMBERS AND NO ISSUES WERE IDENTIFIED. ALTHOUGH THE DEVICE HISTORY RECORDS FOR EACH REPORTED LOT NUMBER IDENTIFIED NO ISSUES WITH FOREIGN MATTER OR SCALE MARKINGS, THE OBSERVED ISSUES HAVE BEEN DETERMINED TO BE RELATED TO THE MANUFACTURING PROCESS. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY.

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED BEFORE USE OF THE SYRINGE LUER-LOK¿ TIP W/TIP SHIELD BULK NON-STERILE THE SYRINGE CONTAINS A PARTICLE OF WOOD AND A WHITE PIECE OF FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857527 SYRINGE LUER-LOK¿ TIP W/TIP SHIELD BULK NON-STERILE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7121846

    Patients

    Seq Age Sex Outcome Treatment
    1 Other