BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

    MDR report key: 12236618 · Received July 28, 2021

    Report

    Report Number
    3002682307-2021-00354
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2101171. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE OF THE AFFECTED SAMPLE WAS PROVIDED AND WAS SUFFICIENT IN CONFIRMING THE REPORTED ISSUE. THE PICTURE PRESENTED A LEAK THROUGH THE PLUNGER ROD COMPONENT. WE HAVE DETERMINED THAT THIS TYPE OF DEFECT WAS MOST LIKELY A CONSEQUENCE OF DAMAGE TO THE PLUNGER LIP COMPONENT. THIS DAMAGE MAY RESULT DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. A QUALITY PROCESS HAS BEEN OPENED WITH THE AIM OF REDUCING THE OCCURRENCE OF THIS TYPE OF DEFECT. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WAREHOUSE MANAGER REPORTS PRODUCT LEAKAGE TO THE MANAGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139350 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101171

    Patients

    Seq Age Sex Outcome Treatment
    1