BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH LUER-LOK¿ TIP

    MDR report key: 7594508 · Received June 12, 2018

    Report

    Report Number
    1911916-2018-00327
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 13, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WAS A DUPLICATE OF MDR REPORT # 1911916-2018-00336 AND IS THEREFORE OVER-REPORTED. (B)(4) IS BEING CANCELLED AS IT WAS OPENED IN ERROR AND IS A DUPLICATE OF (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7170591, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2017-06-19, MEDICAL DEVICE LOT #: 7108961, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-04-18, MEDICAL DEVICE LOT #: 7143799, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-05-23, MEDICAL DEVICE LOT #: 7206506, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. 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 WITH THE USE OF THE BD¿ SYRINGE WITH LUER-LOK¿ TIP THERE WAS AN ISSUE WITH SCALE MARKING. NO FURTHER INFORMATION PROVIDED. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436212 BD¿ SYRINGE WITH LUER-LOK¿ TIP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other