BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE

    MDR report key: 7687790 · Received July 13, 2018

    Report

    Report Number
    8041187-2018-00255
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 15, 2018
    Report Date
    August 17, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057832
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES. CORRECT CATALOG # 305788. CORRECT LOT # 7269238. CORRECT EXPIRATION DATE 2022-09-30. CORRECT MANUFACTURE DATE 2017-09-26.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PHOTO WAS RECEIVED FOR INVESTIGATION. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE AT LUER CONNECTION WITH LOT #7269238 REGARDING ITEM #305788. INVESTIGATION CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ECLIPSE BD LUER-LOK SYRINGE WITH NEEDLE LEAKED. NO REPORTED MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE LEAKED. NO REPORTED MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE ARE TWO 510K'S LISTED: K980987(SYRINGE); K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE LEAKED. NO REPORTED MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528309 BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7269238 00382903057832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other