BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    MDR report key: 10084302 · Received May 22, 2020

    Report

    Report Number
    3002682307-2020-00167
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903012299
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/19/2020. H.6. INVESTIGATION: ONE SEALED SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PRODUCT, A BLACK PARTICLE STAINED WITH GREASE WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1911733, 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. 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 THE ORIGIN OF THE PARTICLE, THE GREASE IS USED FOR LUBRICATION AND LIKELY ORIGINATED FROM THE CHAINS THAT GUIDE THE PAPER AND FILM WITHIN THE PACKAGE MACHINE. QUALITY PROJECT#1690 HAS BEEN INITIATED TO REDUCE FOREIGN MATTER WITHIN OUR PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A PARTICLE WAS DETECTED IN THE SYRINGE BEFORE IT WAS OPENED. PLEASE LET US KNOW WHETHER YOU WOULD LIKE TO HAVE THE PACKAGE COLLECTED FROM US TO CHECK THE QUALITY OR WHETHER YOU WOULD LIKE US TO DESTROY IT."

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A PARTICLE WAS DETECTED IN THE SYRINGE BEFORE IT WAS OPENED. PLEASE LET US KNOW WHETHER YOU WOULD LIKE TO HAVE THE PACKAGE COLLECTED FROM US TO CHECK THE QUALITY OR WHETHER YOU WOULD LIKE US TO DESTROY IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547944 BD PLASTIPAK LUER-LOK 30 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1911733 00382903012299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other