BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿

    MDR report key: 12426322 · Received September 4, 2021

    Report

    Report Number
    3003152976-2021-00564
    Event Type
    Malfunction
    Date Received
    September 4, 2021
    Date of Event
    July 8, 2021
    Report Date
    October 13, 2021
    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

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2102073 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING MANUFACTURING PROCESS BREAK OUT FORCE, SUSTAINING FORCE AND SILICONE CONTENT TESTS ARE PERFORMED, RESULTS FOR LOT 2103048 ARE WITHIN SPECIFICATION LIMITS. 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 PROCEDURES. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ HAD A DIFFICULT TO MOVE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PUSHING THE PLUNGER TO READJUST THE VOLUME AFTER TAKING THE CHEMOTHERAPY, IT GETS STUCK".

    Additional Manufacturer Narrative · 1

    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 WAS REPORTED THAT BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ HAD A DIFFICULT TO MOVE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PUSHING THE PLUNGER TO READJUST THE VOLUME AFTER TAKING THE CHEMOTHERAPY, IT GETS STUCK. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323546 BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2102073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown