BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 514261 · Received February 25, 2004

    Report

    Report Number
    MW1031284
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    February 25, 2004
    Report Date
    February 25, 2004
    Manufacturer
    BECKTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/4/04: EVALUATION DATE/TIME: 11/12/2003 9:27:59 AM. QA RECEIVED 2 LOOSE ULTRA-FINE II SHORT 3/10CC 1/2 UNIT SYRINGES OUT OF OPENED POLY BAG WHICH CUSTOMER CLAIMED THE SCALE MARKINGS ARE OFF 1/2 UNIT. TWO SYRINGES WERE EXAMINED AND WERE FOUND TO BE PRINTED AS PER MFG SPEC. TWO SYRINGES WERE EVALUATED FOR VOLUMETRIC ACCURACY AT 5 AND 30 UNITS. DATA; (AVERAGE OF 2) 0.0504, 02968 (SPEC: 5 UNITS 0.0449-0.0548, 30 UNITS 0.2844-0.3143) ACCURACY WAS FOUND TO BE WITHIN SPECIFICATION. CANNOT CONFIRM MFG DEFECT. NO CORRECTIVE ACTION REQUIRED. EVALUATION DATE/TIME: 05/04/2004 2:53:02 PM. BATCH HISTORY REVIEW CONDUCTED ON THIS LOT (2258288) BY MANUFACTURING. THERE WAS EVIDENCE OF ONE NOTIFICATION FOR SMEARED/SCRATCHED PRINT AT THE PRINTING OPERATION. DEFECT NOTED IN THE DEVICE HISTORY RECORD, HOWEVER, NO OTHER DEFECTS NOTED.

    Description of Event or Problem · 1

    THE SCALE MARKINGS ON THE BARREL OF THE SYRINGE ARE SET LOWER THAN WHAT IT SHOULD BE. THE CALIBRATION HAS AN ERROR. THIS LEADS TO MORE INSULIN BEING DRAWN THAN NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BD ULTRA FINE 2 SYRINGE FMF BECKTON DICKINSON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 2. LANCET DEVICE.| 1. GLUCOSE METER.