BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7687618 · Received July 13, 2018

    Report

    Report Number
    8041187-2018-00254
    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
    FMF
    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

    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 #7362021 REGARDING ITEM #305783 INVESTIGATION CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    CORRECTION: 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: DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    "IT WAS REPORTED THAT THE 22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. CATALOG # HAS TWO: K980987(SYRINGE); K161170 (NEEDLE). 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 THAT THE 22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528266 22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 7362021 00382903057832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other