BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 8364187 · Received February 22, 2019

    Report

    Report Number
    9614033-2019-00112
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 17, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. FURTHERMORE, THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. CORRECTIVE AND PREVENTATIVE ACTION WAS OPENED TO INVESTIGATE THIS FAILURE MODE. CAPA 400567.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAS BEEN LEAKING. THIS OCCURRED ON 4 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K)#: K151766, K980987. 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 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP HAS BEEN LEAKING. THIS OCCURRED ON 4 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157710 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 7319958 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other