BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7768561 · Received August 9, 2018

    Report

    Report Number
    1911916-2018-00440
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 23, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: UNKNOWN. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. THIS IS THE FIRST COMPLAINT FOR THE LOT# 8082759 FOR THE SAME DEFECT OR SYMPTOM. NO RELATED DEFECTS OR QNS WERE RECORDED IN THE DHR. NO PHOTOS OR SAMPLES WERE AVAILABLE TO CONFIRM THE DEFECT. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PHOTOS OR SAMPLES NO CORRECTIVE ACTIONS REQUIRED, ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SYRINGE WITH BD LUER-LOK TIP THERE WAS AN ISSUE WITH STOPPER MISSING. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 BD LUER-LOK¿ TIP THERE WAS AN ISSUE WITH STOPPER MISSING. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612079 BD¿ SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8082759 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other