BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 15407364 · Received September 12, 2022

    Report

    Report Number
    3003152976-2022-00414
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    July 13, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203104, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED IN ANY OF THE PRODUCT, THE TIPS WERE PROPERLY MOLDED, AND NO DEFECTS WERE NOTED IN ANY OF THE LUERS OR SYRINGE TIPS. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURE, NO ISSUES RELATED TO THE EVENT REPORTED WERE FOUND. IT IS POSSIBLE THE LUER WAS DAMAGED DUE TO OVERSCREWING WHEN ENGAGING THIS DEVICE, HOWEVER, WITHOUT A SAMPLE THIS CANNOT BE VERIFIED. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE SYRINGE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING A CARDIO INTERVENTIONAL PROCEDURE, THE SCREW OF THE LL SYRINGE BROKE WHILE TRYING TO UNSCREW IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE SYRINGE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING A CARDIO INTERVENTIONAL PROCEDURE, THE SCREW OF THE LL SYRINGE BROKE WHILE TRYING TO UNSCREW IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534555 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown