BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20ML PRECISE SYRINGE LUER-LOK¿ TIP

    MDR report key: 8021184 · Received October 30, 2018

    Report

    Report Number
    8041187-2018-00407
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 3, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    GAA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ACTUAL SAMPLE IN OPEN PACKAGE WAS RETURNED FOR INVESTIGATION. THE SAMPLE WAS SUBJECTED TO PLUNGER BREAKOUT AND SUSTAINING FORCE TEST PER TEST PROCEDURE (B)(4). RESULT SHOWED BREAKOUT AND SUSTAINING FORCE IS WITHIN THE PRODUCT SPECIFICATION. REVIEWED THE DHR, ROUTINE SILICON TEST AND BREAKOUT & SUSTAINING FORCE TEST PASSED THE PRODUCT SPECIFICATION. THE 1 ACTUAL SAMPLE PASSED THE BREAKOUT & SUSTAINING FORCE TEST. HENCE, ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE 20ML PRECISE SYRINGE LUER-LOK TIP THERE WAS AN ISSUE WITH DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE 20ML PRECISE SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861330 20ML PRECISE SYRINGE LUER-LOK¿ TIP CONVENTIONAL SYRINGE GAA BECTON DICKINSON MEDICAL (SINGAPORE) 8141392

    Patients

    Seq Age Sex Outcome Treatment
    1 Other