BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD¿ SLIP TIP SYRINGE

    MDR report key: 6866450 · Received September 14, 2017

    Report

    Report Number
    1213809-2017-00111
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Report Date
    December 4, 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
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR REVIEW FOR BATCH 7001803 (P/N 309701): MANUFACTURING DATES: 2/23/2017 - 2/24/2017. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. A QUALITY NOTIFICATION REVIEW INDICATES THAT A QUALITY NOTIFICATION (#200679420) WAS GENERATED ON 02/24/2017 FOR DAMAGED BARRELS AND MISSING PRINT DURING THE MANUFACTURE OF BATCH 7001803. PRODUCTION WAS STOPPED AND PRODUCT REQUALIFIED PER APPLICABLE AQL. BATCH 7001803 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE LOOSE 1ML SYRINGE WITH WAS RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7001803 (P/N 309701). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE DAMAGE TO THE SYRINGE FLANGE AND THE BARREL WALL. THE BARREL PRINT HAS BEEN RUBBED OFF DUE TO BARREL DAMAGE. THE DEFECTS OBSERVED APPEAR TO BE CONSISTENT WITH THE DEFECTS REPORTED IN THE QN DURING THE MANUFACTURE OF BATCH 7001803. BASED ON THE SAMPLE EVALUATION: ¿ CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1 ML BD SLIP TIP SYRINGE WAS BENT AND HAD ILLEGIBLE MARKINGS ON THE SYRINGE, FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646712 1 ML BD¿ SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7001803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other