BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 20X1 RB

    MDR report key: 8828152 · Received July 25, 2019

    Report

    Report Number
    1213809-2019-00766
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095781
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND TOTAL OF 1,757 SEALED AND PACKAGED 3ML SYRINGES, CONFIRMED TO BE FROM BATCH 9072981 (B)(4),WERE RECEIVED AND EVALUATED. IT WAS OBSERVED 3 OF THE SYRINGES HAD VARYING DEGREES OF SKEWED SCALE RESULTING IN MISSING PRINT IN THE SCALE MARKINGS. TWO OF THE SYRINGES WERE MISSING THE ¿2¿ OF THE ¿1/2¿ ML MARKING. ONE SYRINGE WAS MISSING ALL NUMBERS BELOW THE 11/2 ML MARKING AND THE ¿1/2¿ FROM THE ¿11/2¿ MARKING, MAKING IT APPEAR AS ¿1.¿ THE SCALE MARKING DEFECT OBSERVED IN ALL 3 OF THE SYRINGES WAS FOUND TO BE REJECTABLE PER PRODUCT SPECIFICATION. NO SCALE MARKING DEFECTS WERE OBSERVED IN 1,754 REMAINING SYRINGES. MACHINE LOGS INDICATE MARKER ISSUES WERE PRESENT DURING THE MANUFACTURE OF THIS BATCH. POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE DEFECT IS ASSOCIATED WITH EQUIPMENT SETUP. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKING ERROR WAS FOUND BEFORE USE WITH SYRINGES 3ML LL W/NDL 20X1 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE MEASUREMENT MARKINGS ARE OFF ON THIS BATCH OF SYRINGES."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCALE MARKING ERROR WAS FOUND BEFORE USE WITH SYRINGES 3ML LL W/NDL 20X1 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE MEASUREMENT MARKINGS ARE OFF ON THIS BATCH OF SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623218 SYRINGE 3ML LL W/NDL 20X1 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9072981 30382903095781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other