BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 15588256 · Received October 12, 2022

    Report

    Report Number
    3003152976-2022-00464
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 7, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 17-OCT-2022. H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A HAIR WAS OBSERVED INSIDE THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203058, 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. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE ROOT CAUSE OF THIS INCIDENT IS DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. =

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHILE DRAWING UP SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE DRAWING UP SALINE IN THE ISOLATOR ONE OF OUR TECHNICIANS NOTICED A HAIR INSIDE ONE OF YOUR 50ML BD PLASTIPAK SYRINGES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHILE DRAWING UP SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE DRAWING UP SALINE IN THE ISOLATOR ONE OF OUR TECHNICIANS NOTICED A HAIR INSIDE ONE OF YOUR 50ML BD PLASTIPAK SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628906 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203058 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown