BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 16698910 · Received April 7, 2023

    Report

    Report Number
    3003152976-2023-00121
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 15, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    INVESTIGATION SUMMARY: NO SAMPLES OR PICTURES RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2210033, 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 AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. 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. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT AND REDUCE PARTICLES FROM GENERATING. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, POSSIBLE ROOT CAUSE IS CONTAMINATION DURING ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FLAKES OF FOREIGN MATTER WERE FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "SOME SYRINGES HAVE MATERIAL THAT COMES OFF DURING USE... CONFIRMED THAT THE ISSUE IS THAT THE CUSTOMER IS OBSERVING WHITE FLAKES INSIDE THE SYRINGE, AS IF PLASTIC FROM THE SYRINGE WOULD HAVE DETACHED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FLAKES OF FOREIGN MATTER WERE FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "SOME SYRINGES HAVE MATERIAL THAT COMES OFF DURING USE. ... CONFIRMED THAT THE ISSUE IS THAT THE CUSTOMER IS OBSERVING WHITE FLAKES INSIDE THE SYRINGE, AS IF PLASTIC FROM THE SYRINGE WOULD HAVE DETACHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731328 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown