BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE

    MDR report key: 15830424 · Received November 19, 2022

    Report

    Report Number
    1213809-2022-01052
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 27, 2022
    Report Date
    January 16, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 19-DEC-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED PACKAGE ARE NOT PROPERLY CLOSED. TO AID IN THE INVESTIGATION, THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. POTENTIAL ROOT CAUSE FOR THE OPEN SEAL DEFECTS IS ASSOCIATED WITH THE WITH A FAILURE TO PROPERLY CHANGE THE TOP WEB, AND DEFICIENCIES RELATED TO THE WEB CHANGE PROCEDURE. WORK INSTRUCTION PROCEDURE FOR CHANGING TOP WEBS HAS BEEN UPDATED TO MITIGATE THIS DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1181131. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGES' PACKAGING UNITS HAD RIPS/HOLES IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT NOT STERILE DUE TO THAT PACKAGE ARE NOT PROPERLY BLISSED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGES' PACKAGING UNITS HAD RIPS/HOLES IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT NOT STERILE DUE TO THAT PACKAGE ARE NOT PROPERLY BLISSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254922 BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1181131 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown