BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE WITH NEEDLE

    MDR report key: 9643991 · Received January 29, 2020

    Report

    Report Number
    3002682307-2020-00020
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 18, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 300294 LOT 1910516 TO INVESTIGATE FOR THIS RECORD. BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BASED ON THE CUSTOMER FEEDBACK AND AFTER DISCUSSING THE REPORTED ISSUE WITH OUR MANUFACTURING TECHNICIANS, BD BELIEVES THE CAUSE OF THE PROBLEM COULD BE RELATED WITH SOME UNEXPECTED TEMPORARY PROBLEM IN THE PRINTING MACHINE. THEREFORE, THE REPORTED SHELF CARTON LABEL WAS NOT PRINTED. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT II¿ SYRINGE WITH NEEDLE HAS BEEN FOUND EXPERIENCING 100 OCCURRENCES OF MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE IS BLANK LABEL ON OUTER CARTON OF EMERALD 10ML.

    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 HAS BEEN REPORTED THAT THE BD DISCARDIT II¿ SYRINGE WITH NEEDLE HAS BEEN FOUND EXPERIENCING 100 OCCURRENCES OF MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE IS BLANK LABEL ON OUTER CARTON OF EMERALD 10ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108335 BD DISCARDIT II SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1910516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other