BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC LL SYRINGE P-LK O/P

    MDR report key: 5883653 · Received August 17, 2016

    Report

    Report Number
    1017768-2016-00065
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Report Date
    August 15, 2016
    Manufacturer
    COVIDIEN
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 8/17/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/08/2016. A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. THERE WAS 1 SAMPLE (OPENED) RETURNED WITH THIS COMPLAINT. THE SAMPLE HAD A THIN CRACK, APPROXIMATELY 1 INCH IN LENGTH, WHICH RAN AXIALLY ALONG THE SYRINGE BARREL. THE CRACK WAS ACCOMPANIED WITH A FAINT SCRATCH THAT RAN ALONG THE SAME LINE AS THE CRACK. THE SAMPLE WAS INSPECTED FOR LEAKS AND FAILED TESTING. THE REPORTED CONDITIONS OF DAMAGE AND SYRINGE LEAKING ARE CONFIRMED. THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED BASED ON AVAILABLE INFORMATION. THE MOST LIKELY ROOT CAUSE IS DUE TO A COMPONENT JAM OR MISALIGNED PIECE OF EQUIPMENT. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE INSPECTED FOR DAMAGE AND LEAKAGE IN THE FLUID PATHWAY. THE LOTS MET ALL DEFINED ACCEPTANCE CRITERIA AND WERE RELEASED. THE EXACT ROOT CAUSE FOR THE REPORTED CONDITION COULD NOT BE SPECIFICALLY IDENTIFIED SO A CORRESPONDING CORRECTIVE ACTION COULD NOT BE TAKEN. HOWEVER, DUE TO COMPLAINTS FOR RELATED ISSUES FROM THE FIELD, CORRECTIVE ACTIONS WERE TAKEN TO ADD TROUBLESHOOTING GUIDES TO THE OPERATING PROCEDURE. TROUBLESHOOTING SECTION WAS INITIATED TO PROCEDURE AND NEW STANDARD WORK DOCUMENTS WERE CREATED FOR TROUBLESHOOTING EQUIPMENT ISSUES. THIS COMPLAINT WILL BE RECORDED FOR TRENDING PURPOSES AND USED TO ASSESS THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER STATES THE SYRINGE IS CRACKED. THE NURSES FILL UP WHEN DRAWING MEDS AND WHEN PRESSURE IS APPLIED TO THE PLUNGER THE MEDS SQUIRT OUT OF THE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536163 3CC LL SYRINGE P-LK O/P SYRINGE MEG COVIDIEN 8881513934 615400

    Patients

    Seq Age Sex Outcome Treatment
    1