BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12308392 · Received August 11, 2021

    Report

    Report Number
    3003152976-2021-00467
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 14, 2021
    Report Date
    September 3, 2021
    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

    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: 8/4/2021. H.6. INVESTIGATION: ONE PHYSICAL SAMPLE AND ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A WHITE PARTICLE WAS OBSERVED OUTSIDE OF THE FLUID PATH BETWEEN THE BARREL AND THE PLUNGER. AFTER FURTHER EVALUATION, THE PARTICLE APPEARED TO BE PAPER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2003240, 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. GIVEN THE DEVICE RECORDS DO NOT INDICATE ANY ISSUES RELATED TO THIS ISSUE AND MANUFACTURING RECORDS ESTABLISH ALL QUALITY PROCESSES WERE CARRIED OUT ACCORDING TO PROCEDURE, WE CANNOT IDENTIFY A DEFINITIVE SOURCE FOR THE PAPER AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIBROUS, FOREIGN MATERIAL WAS FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHEN REMOVED FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LARGE FIBROUS MATERIAL NOTED ONCE SYRINGE WAS TAKEN OF PACKAGING -PACKAGING WAS NOT RETAINED; THE PRODUCT WAS FOUND WITHIN OUR ASEPTIC UNIT AND AN ALTERNATIVE NEEDED TO BE OBTAINED IN ORDER TO PROCESS WITH THE PREPARATION."

    Additional Manufacturer Narrative · 1

    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 FIBROUS, FOREIGN MATERIAL WAS FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHEN REMOVED FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LARGE FIBROUS MATERIAL NOTED ONCE SYRINGE WAS TAKEN OF PACKAGING -PACKAGING WAS NOT RETAINED; THE PRODUCT WAS FOUND WITHIN OUR ASEPTIC UNIT AND AN ALTERNATIVE NEEDED TO BE OBTAINED IN ORDER TO PROCESS WITH THE PREPARATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203845 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003240

    Patients

    Seq Age Sex Outcome Treatment
    1