BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17720773 · Received September 11, 2023

    Report

    Report Number
    1213809-2023-00990
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3110973. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE BARREL CRACK INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. SHORT COUNT IN PACKAGES WERE BY ACKNOWLEDGED BY QUALITY ENGINEER BASED ON REPORTED INFORMATION. POTENTIAL ROOT CAUSE FOR THE SHORT COUNT DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THIS DEFECT IS OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. HOWEVER, ISSUE REPORTED FOR BARREL CRACK WAS NOT CONFIRMED WITH LIMITED INFORMATION. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H3. 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 2 OF THE BD PLASTIPAK¿ SYRINGES WERE CRACKED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: DURING COMPOUNDING IT WAS NOTICED THAT 1 TRAY CONTAINED TWO CRACKED SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ SYRINGES WERE CRACKED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: DURING COMPOUNDING IT WAS NOTICED THAT 1 TRAY CONTAINED TWO CRACKED SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138904 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3110973 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown