BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7190384 · Received January 15, 2018

    Report

    Report Number
    1213809-2017-00441
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 21, 2017
    Report Date
    March 15, 2018
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: 74 SEALED 3ML PACKAGED SYRINGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7212710 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE MISSING PRINT AND INK RINGS. DHR REVIEW FOR BATCH 7212710 (P/N 309657): MANUFACTURING DATE: 08/24/2017 TO 08/25/2017. BATCH QUANTITY WAS 767,800. PRINTING AND ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. PRINT ISSUES WERE NOTED DURING THE MANUFACTURE OF THIS BATCH AND ADJUSTMENTS TO THE PRINTER WERE MADE. PRODUCT WAS REQUALIFIED PER APPLICABLE AQL. BATCH 7212710 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. INVESTIGATION CONCLUSION: POTENTIAL ROOT CAUSE: MALFUNCTIONING DOCTOR BLADE AND INK SYSTEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP THE DOSAGE LINES ON SYRINGES ARE SMUDGED AND FADED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35908 BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212710 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other