BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 8350369 · Received February 19, 2019

    Report

    Report Number
    1213809-2019-00225
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    February 4, 2019
    Report Date
    April 24, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND 162 SEALED PACKAGED 3ML SYRINGES, CONFIRMED TO BE FROM BATCH #8213796 (P/N 309657) WERE RECEIVED AND VISUALLY EVALUATED. THE PHOTOS DEPICT TWO SYRINGES: ONE SYRINGE WITH A SKEWED SCALE AND PARTIAL MISSING NUMBERS TO THE RIGHT OF THE SCALE, SPECIFICALLY ½, 1 AND PARTS OF 1 ½ AND 2; ONE SYRINGE WITH MISSING PRINT BUT NO SKEW TO THE SCALE ¿ ALL SCALE MARKINGS BETWEEN ZERO LINE AND 1ML WAS MISSING IN THIS SYRINGE. THE 162 RETURNED SYRINGES WERE VISUALLY EVALUATED AND WERE FOUND TO HAVE NO PRINT DEFECTS. ALL HAD SCALES MARKINGS PRINTED CORRECTLY. 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. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8213795 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SCALE MARKING ARE NOT PRINTED CORRECTLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SCALE MARKING ARE NOT PRINTED CORRECTLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143233 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8213795 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other