BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER LOK SYRINGE

    MDR report key: 8915798 · Received August 21, 2019

    Report

    Report Number
    3003152976-2019-00570
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE THUMB PRESS OF THE SYRINGE IS NOTED TO BE BROKEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1812363 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE DAMAGE LIKELY OCCURRED AS A RESULT OF THE PRODUCT GETTING JAMMED WITHIN THE MANUFACTURING EQUIPMENT. PORTIONS WHERE THE PRODUCT MOVES WITHIN THE MANUFACTURING LINE ARE PROTECTED TO AVOID CREATING ANY DAMAGE TO THE PRODUCT. A PROJECT HAS BEEN INITIATED TO LOOK FURTHER INTO THIS ISSUE AND REDUCE ANY REOCCURRENCES. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD PLASTIPAK¿ LEUR LOK SYRINGE HAS BEEN FOUND WITH A BROKEN PLUNGER ROD BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PLUNGER OF THE SYRINGE WAS RECEIVED BROKEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD PLASTIPAK¿ LEUR LOK SYRINGE HAS BEEN FOUND WITH A BROKEN PLUNGER ROD BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PLUNGER OF THE SYRINGE WAS RECEIVED BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712781 BD PLASTIPAK LUER LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1812363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other