BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 9213567 · Received October 21, 2019

    Report

    Report Number
    9614033-2019-00262
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 4, 2019
    Report Date
    January 27, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 194 SAMPLES RECEIVED FOR INVESTIGATION, SAMPLES WERE ANALYZED FOR SUSTAINING FORCE AND MOLDING DEFECTS IN THE BARREL, PLUNGER, AND/OR STOPPER. RESULTS WERE COMPLIANT, NO DEFECT FOUND. ADDITIONALLY, SAMPLES WERE VISUALLY ANALYZED FOR DAMAGED PLUNGER, NO DEFECTS OBSERVED. THE DEFECT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO CORRECTIVE ACTIONS ARE NECESSARY. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP PLUNGER ROD WAS BROKEN. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9071959. IT WAS REPORTED THAT WHEN PULLING BACK ON THE PLUNGER TO DRAW UP MEDICATION, ALL THAT IS RECEIVED IS AIR. REPORTED ISSUE: CUSTOMER STATES THAT WHEN PULLING BACK ON THE PLUNGER TO DRAW OUT THE MEDICATION ALL THAT COMES INTO THE SYRINGE IS AIR. SOME OF THEM WILL PULL OUT A FEW DROPS OF THE SOLUTION BUT THAT'S IT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PLUNGER ROD WAS BROKEN. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: 9071959. IT WAS REPORTED THAT WHEN PULLING BACK ON THE PLUNGER TO DRAW UP MEDICATION, ALL THAT IS RECEIVED IS AIR. REPORTED ISSUE: CUSTOMER STATES THAT WHEN PULLING BACK ON THE PLUNGER TO DRAW OUT THE MEDICATION ALL THAT COMES INTO THE SYRINGE IS AIR. SOME OF THEM WILL PULL OUT A FEW DROPS OF THE SOLUTION BUT THAT'S IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010824 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 9071959 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other