BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 15491698 · Received September 27, 2022

    Report

    Report Number
    1213809-2022-00644
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 19, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096053
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 10-OCT-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A SEVERE INDENTATION OBSERVED ON THE TOP OF THE BARREL COLLAR. POTENTIAL ROOT CAUSE FOR THE DAMAGED COLLAR DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS CONDITION IS OCCURRING BELOW THEIR EXPECTED FREQUENCY SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1200434. 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 THE BD SYRINGE LUER-LOK¿ TIP ARE DENTED/CHIPPED OFTEN CAUSING THE SYRINGE TO LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIPS OF THE SYRINGES ARE DENTED/CHIPPED AND OFTEN CAUSING THE SYRINGES TO LEAK. WE HAVE SEEN 10-15 SYRINGES WITH THIS DEFECT SO FAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP ARE DENTED/CHIPPED OFTEN CAUSING THE SYRINGE TO LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIPS OF THE SYRINGES ARE DENTED/CHIPPED AND OFTEN CAUSING THE SYRINGES TO LEAK. WE HAVE SEEN 10-15 SYRINGES WITH THIS DEFECT SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078417 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1200434 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown