BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 15709411 · Received November 1, 2022

    Report

    Report Number
    2243072-2022-01867
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 8, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THERE ARE NO SAMPLES, BUT ONE PHOTOGRAPH WAS RECEIVED FROM THE CUSTOMER ALONG WITH THE REPORTED COMPLAINT OF ¿LABEL CONTENT MISSING¿. THE INVESTIGATING TEAM USED RETENTION SAMPLES OF MATERIAL #307753 FROM LOT #2161725 FOR INVESTIGATING THE REPORTED DEFECT. BASED ON THE PHOTOGRAPH THE DEFECT WAS CONFIRMED. THE DHR OF LOT NUMBER 2161725 OF MATERIAL NO. 307753 WAS REVIEWED FOR QN AND THERE WAS NO QN RAISED ON THIS LOT NUMBER FROM ITS PRODUCTION TO ITS DISPATCH.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 · 0

    IT WAS REPORTED THAT 1,800 BD EMERALD SYRINGES EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CASE OF EMERALD 3ML 23G SYRINGE RECEIVED HAD BOXES WITH NO DETAILS OF BATCH NO. EXPIRY DATE, MRP ETC. PRINTED ON THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1,800 BD EMERALD SYRINGES EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CASE OF EMERALD 3ML 23G SYRINGE RECEIVED HAD BOXES WITH NO DETAILS OF BATCH NO. EXPIRY DATE, MRP ETC. PRINTED ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059477 BD EMERALD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2161725

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown