BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE

    MDR report key: 8317247 · Received February 7, 2019

    Report

    Report Number
    8041187-2019-00137
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 1, 2015
    Report Date
    February 15, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057788
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES AND PHOTOS DISPLAYING THE REPORTED CONDITION WERE RECEIVED NO DEFECTS CAN BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. ROOT CAUSE COULD NOT BE DETERMINED AS THERE IS NO SAMPLE RETURNED FOR INVESTIGATION. FOR THE DURATION OF THE LAST 12 MONTHS, THERE WAS NO QUALITY NOTIFICATION RAISED FOR A SIMILAR NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE HAD A LOOSE PLUNGER AND DISCHARGED MEDICATION FROM THE PLUNGER.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 01/08/2019, MEDWATCH # MW5082288. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. PMA / 510(K)#: K941562 (SYRINGE); K010188 (NEEDLE). MEDICAL DEVICE TYPE: FMI / FMF. 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 A 30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE HAD A LOOSE PLUNGER AND DISCHARGED MEDICATION FROM THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111924 30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN 00382903057788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other