BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 8771463 · Received July 9, 2019

    Report

    Report Number
    9614033-2019-00179
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    April 1, 2019
    Report Date
    July 11, 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 · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL 200 S/C HAS EXPERIENCED TWO CASES OF DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657 BATCH NO. 8222980. IT WAS REPORTED THERE IS RESISTANCE WHILE DRAWING INSULIN. DESCRIPTION OF ISSUE: CUSTOMER REPORTED FILL RESISTANCE WHILE DRAWING INSULIN FROM THE VIAL (NOT THE CARTRIDGE). EVENT DATE IS TENTATIVE AS CUSTOMER REPORTED IT HAPPENED WITHIN THE LAST 2 MONTHS. CUSTOMER REPORTED SHE WOULD CHANGE OUT SYRINGE WHILE STILL USING THE SAME CARTRIDGE EACH TIME TO LOAD INSULIN INTO THE CARTRIDGE, COMPLETE LOAD SEQUENCE, AND RESUME INSULIN THERAPY ON THE PUMP.

    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 HAS BEEN REPORTED THAT THE SYRINGE 3 ML LL 200 S/C HAS EXPERIENCED TWO CASES OF DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657, BATCH NO. 8222980. IT WAS REPORTED THERE IS RESISTANCE WHILE DRAWING INSULIN. DESCRIPTION OF ISSUE: CUSTOMER REPORTED FILL RESISTANCE WHILE DRAWING INSULIN FROM THE VIAL (NOT THE CARTRIDGE). EVENT DATE IS TENTATIVE AS CUSTOMER REPORTED IT HAPPENED WITHIN THE LAST 2 MONTHS. CUSTOMER REPORTED SHE WOULD CHANGE OUT SYRINGE WHILE STILL USING THE SAME CARTRIDGE EACH TIME TO LOAD INSULIN INTO THE CARTRIDGE, COMPLETE LOAD SEQUENCE, AND RESUME INSULIN THERAPY ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564182 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222980 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other