BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8759907 · Received July 3, 2019

    Report

    Report Number
    9614033-2019-00178
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 17, 2019
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. TEN PIECES OF RETENTION SAMPLES WERE ANALYZED FOR A VISUAL AND FUNCTIONAL EVALUATION IN ORDER TO VERIFY THE DEFECT THAT THE CLIENT REPORTS. THE RETENTION SAMPLES PRESENTED SATISFACTORY RESULTS, NO DEFECT OBSERVED WITH DEFORMATION OF THE THREAD OR NOZZLE OF SYRINGE. 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. INVESTIGATION CONCLUSION: NO PHYSICAL SAMPLE OR CUSTOMER PHOTOGRAPH IS RECEIVED TO EVALUATE THE REPORTED LUER DAMAGED. ROOT CAUSE DESCRIPTION: DURING THE REVIEW OF THE BATCH NO PROBLEM ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CUSTOMER WAS DETECTED. RATIONALE: 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.

    Description of Event or Problem · 1

    MATERIAL NO. 309657, BATCH NO. 8222920. IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP THE LUER WAS DAMAGED. THERE WERE TWO OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT CARTRIDGE WAS DEFECTED AT THE AREA WHEN SHE USUALLY INSERT THE NEEDLE WITH INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554971 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222920 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other