BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 15529132 · Received October 3, 2022

    Report

    Report Number
    3003152976-2022-00450
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 8, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A WHITE FOREIGN MATTER WAS OBSERVED ON THE STOPPER. VISUAL CHARACTERISTICS INDICATE THE SUBSTANCE IS LIKELY POLYPROPYLENE DUST MIXED WITH SILICONE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203152, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER USED TO REMOVE ANY POLYPROPYLENE PARTICLES INSIDE THE BARREL. MANUFACTURING EQUIPMENT IS PROTECTED TO AVOID PARTICLES FROM GENERATING DURING MOVEMENT OF THE PIECES WITHIN THE MACHINES. 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE PARTICLES LIKELY GENERATED DURING THE MOVEMENT OF THE PRODUCT WITHIN THE MANUFACTURING EQUIPMENT. A PROJECT WAS INITIATED TO REDUCE ANY FOREIGN PARTICLES INSIDE OUR PRODUCTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A WHITE SUBSTANCE STUCK ON THE TOP OF PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS A DRUG WAS BEING DRAWN UP IN ISOLATOR ROOM, THE OPERATOR NOTICED A WHITE SUBSTANCE STUCK TO THE TOP OF THE SYRINGE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A WHITE SUBSTANCE STUCK ON THE TOP OF PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS A DRUG WAS BEING DRAWN UP IN ISOLATOR ROOM, THE OPERATOR NOTICED A WHITE SUBSTANCE STUCK TO THE TOP OF THE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384246 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown