BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 9383501 · Received November 27, 2019

    Report

    Report Number
    9614033-2019-00279
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 7, 2019
    Report Date
    January 21, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO SAMPLES RECEIVED FOR INVESTIGATION, MOLDING DEFECT AND LEAKAGE TEST WERE PERFORMED. SAMPLES PRESENTED LEAKAGE DEFECT. CAPA 1132752 IS CURRENTLY UNDER INVESTIGATION, WHICH SEEKS TO IDENTIFY POSSIBLE FAILURE MODES THAT CAUSE THE DEFECT, AS WELL AS POSSIBLE IMPROVEMENTS, AS WELL, IT SHOULD BE NOTED THAT THE LOT WAS MANUFACTURED PRIOR TO THE CLOSURE OF THE CAPA. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS LEAKING. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657, BATCH NO.: 9048589. IT WAS REPORTED THAT TWO SYRINGES WERE LEAKING. VERBATIM: TWO BD 3 ML SYRINGE WITH LUER-LOK TIPS LEAKING - THEY CONNECT CORRECTLY, BUT LEAK. THE BOX WITH THIS LOT NUMBER HAS BEEN RETURNED TO OUR PURCHASING DEPARTMENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS LEAKING. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 9048589. IT WAS REPORTED THAT TWO SYRINGES WERE LEAKING. VERBATIM: TWO BD 3 ML SYRINGE WITH LUER-LOK TIPS LEAKING - THEY CONNECT CORRECTLY, BUT LEAK. THE BOX WITH THIS LOT NUMBER HAS BEEN RETURNED TO OUR PURCHASING DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182358 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 9048589 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other