BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL EUROGRAPHICS

    MDR report key: 9186858 · Received October 14, 2019

    Report

    Report Number
    1213809-2019-01034
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 27, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE 10ML SYRINGE IN A FULLY SEALED BLISTER PACK FROM BATCH 9142984 (P/N 300912) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SCALE BEGAN TO SKEW AND ILLEGIBLE PRINT WAS PRESENT ABOVE THE 5ML MARKING. THE ILLEGIBLE PRINT WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE ILLEGIBLE PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9142984 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL EUROGRAPHICS EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SCALE MARKING ISSUE: ILEGIBLE, IT IS REMOVED.

    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 10ML LL EUROGRAPHICS EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SCALE MARKING ISSUE: ILLEGIBLE, IT IS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983176 SYRINGE 10ML LL EUROGRAPHICS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9142984 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other