BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14245572 · Received April 28, 2022

    Report

    Report Number
    3003152976-2022-00176
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 24, 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 AS A DEFAULT. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 04-MAY-2022. INVESTIGATION SUMMARY: SEVERAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND GREASE WAS FOUND ON ONE OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110092, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. MACHINES ROUTINELY UNDERGO PROPER MAINTENANCE AND CLEANING, QUALITY RECORDS ESTABLISH AS PROCESSES WERE CARRIED OUT NORMALLY. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS INCIDENT LIKELY OCCURRED DURING THE MOLDING PROCESS, THE GREASE ACCUMULATING WITHIN THE MOLD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRT FOUND INSIDE OF THE SYRINGE PACKAGING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRT FOUND INSIDE OF THE SYRINGE PACKAGING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115133 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown