BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7364411 · Received March 22, 2018

    Report

    Report Number
    1213809-2018-00190
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE LOOSE 1ML LL ASSEMBLED SYRINGE WAS RECEIVED BY (B)(4) AND REPORTED TO BE FROM EITHER BATCH #7054884 OR 7121638 (P/N 309648). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE MISSING PRINT. THE ENTIRE SYRINGE IS MISSING MORE THAN 50% OF THE PRINTED SCALE. THE AMOUNT OF MISSING PRINT OBSERVED IS REJECTABLE PER CANAAN INTERNAL PRINT STANDARDS. BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CAN BE VERIFIED. DHR REVIEW FOR BATCH 7054884 (P/N 309648): MANUFACTURING DATES: 03/02/2017 TO 03/03/2017. BATCH QUANTITY WAS (B)(4). PRINTING RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7054884 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7121638 (P/N 309648): MANUFACTURING DATES: 05/18/2017 TO 05/19/2017. BATCH QUANTITY WAS (B)(4). PRINTING RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7121638 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7054884, MEDICAL DEVICE EXPIRATION DATE: 02/28/2022, DEVICE MANUFACTURE DATE: 02/23/2017. MEDICAL DEVICE LOT #: 7121638, MEDICAL DEVICE EXPIRATION DATE: 04/30/2022, DEVICE MANUFACTURE DATE: 05/01/2017. (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

    IT WAS REPORTED BEFORE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS INCORRECT SCALE MARKINGS AS THE CUSTOMER STATES ¿ON THE SYRINGE ONLY HALF OF THE SCALE IS PRINTED.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204130 BD LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other