BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9198210 · Received October 16, 2019

    Report

    Report Number
    1213809-2019-01053
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    October 2, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    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: ONE PHOTO OF A 3ML SYRINGE IN A FULLY SEALED BLISTER PACK WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE WAS MISSING SCALE MARKINGS ABOVE THE 2ML LINE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS AND WITH FAILURE TO CONTAIN DEFECT. DHR WAS PERFORMED AND MISSING PRINT WAS FOUND DURING THE MANUFACTURE OF THE BATCH AND ADJUSTMENTS WERE MADE TO ADDRESS THE ISSUE. ACTIONS WERE TAKEN TO CONTAIN THE DEFECT, INCLUDING FULL CLEARING OF THE MANUFACTURING LINE AND REQUALIFICATION OF PACKAGED PRODUCT PER APPLICABLE AQL. IT IS POSSIBLE THAT SMALL AMOUNT OF PRODUCT ESCAPED DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED LIGHT SCALE MARKINGS WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9130794. PER CUSTOMER EMAIL: TODAY IT WAS BROUGHT TO MY ATTENTION THAT OUR 3ML SYRINGE PART# 309657, LOT# 9130794 IS DEFECTIVE. THE MEASUREMENT SCALE PRINTED ON THE SYRINGE IS INCOMPLETE.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED LIGHT SCALE MARKINGS WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9130794. PER CUSTOMER EMAIL: TODAY IT WAS BROUGHT TO MY ATTENTION THAT OUR 3ML SYRINGE PART# 309657, LOT# 9130794 IS DEFECTIVE. THE MEASUREMENT SCALE PRINTED ON THE SYRINGE IS INCOMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993042 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9130794 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other