BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 9672066 · Received February 5, 2020

    Report

    Report Number
    1213809-2020-00060
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 7, 2020
    Report Date
    March 20, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903097036
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED FINAL LOT NUMBER 9213456 AND ALL APPLICABLE SUB-ASSEMBLY LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS ISSUE, ONE SEALED TRAY OF TWENTY-FIVE SYRINGES WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SYRINGES WERE EXAMINED AND SIX OF THE SYRINGES WERE FOUND TO HAVE SCUFF MARKS ON THE FLANGE COMPONENT. ONE OF THE SYRINGES HAD A PLASTIC FOREIGN MATTER PARTICLE BEHIND THE STOPPER COMPONENT, OUTSIDE OF THE FLUID PATHWAY. ALL TWENTY-FIVE SAMPLES WERE TESTED FOR LEAKAGE PER PROCEDURE; HOWEVER, NO SIGNS OF LEAKAGE WERE OBSERVED IN ANY OF THE SAMPLES. BASED ON THE INVESTIGATION RESULTS, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR POTENTIAL SIGNS OF LEAKAGE AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE IN THE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED PAST THE STOPPER BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 14TH OF 14 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LARGE NUMBER OF LEAKING SYRINGES LEADING TO HIGH REJECT RATES IN FINISHED PRODUCT. LEAKING SYRINGES IDENTIFIED DURING VISUAL INSPECTION OF FINISHED PRODUCT." 'THESE LOTS WERE LEAKING PAST THE STOPPER."

    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 THE BD LUER-LOK¿ SYRINGE IN THE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED PAST THE STOPPER BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 14TH OF 14 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LARGE NUMBER OF LEAKING SYRINGES LEADING TO HIGH REJECT RATES IN FINISHED PRODUCT. LEAKING SYRINGES IDENTIFIED DURING VISUAL INSPECTION OF FINISHED PRODUCT." "THESE LOTS WERE LEAKING PAST THE STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137947 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9213456 00382903097036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other