BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 13839042 · Received March 21, 2022

    Report

    Report Number
    3003152976-2022-00110
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 28, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 18-JUL-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BLACK PLASTIC-LIKE PARTICLE WAS OBSERVED ON THE STOPPER OF THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2112036, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS COMPONENT IS PROVIDED BY AN EXTERNAL SUPPLIER. INCOMING INSPECTIONS ARE PERFORMED ACCORDING TO PROCEDURE. 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, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE FOUND. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A DEFECTIVE STOPPER WITH A STRING-LIKE PIECE OF FOREIGN MATTER ATTACHED TO IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) "I WOULD LIKE TO REPORT A PRODUCTION ERROR WITH A 20 ML BD SYRINGE WITH LUER. IT CONCERNS LOTNR 21112036... HOPEFULLY THIS IS A ONE-OFF FAULTY SPECIMEN, AS IT WOULD BE UNTHINKABLE TO INJECT THE PARTICLE INTO A PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A DEFECTIVE STOPPER WITH A STRING-LIKE PIECE OF FOREIGN MATTER ATTACHED TO IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "I WOULD LIKE TO REPORT A PRODUCTION ERROR WITH A 20 ML BD SYRINGE WITH LUER. IT CONCERNS LOTNR 21112036... HOPEFULLY THIS IS A ONE-OFF FAULTY SPECIMEN, AS IT WOULD BE UNTHINKABLE TO INJECT THE PARTICLE INTO A PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517768 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300613 2112036 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown