BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE

    MDR report key: 7794216 · Received August 17, 2018

    Report

    Report Number
    8041187-2018-00285
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    July 25, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE OR PHOTO WAS RECEIVED IN SUPPORT OF THIS COMPLAINT. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: NOT ABLE TO DETERMINE A ROOT CAUSE. 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: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 3 ML BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY THIN WALL NEEDLE HAD FOREIGN MATTER EJECT FROM THE DEVICE WHEN THE PLUNGER WAS PUSHED DOWN BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THIS DEVICE HAS MULTIPLE 510KS ASSOCIATED WITH THE DEVICE: K161170(NEEDLE), K980987(SYRINGE)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE HAD FOREIGN MATTER EJECT FROM THE DEVICE WHEN THE PLUNGER WAS PUSHED DOWN BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636579 3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE HYPODERMIC SYRINGE WITH NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5288042 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other