BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 112 S-PLK SP

    MDR report key: 6285087 · Received January 27, 2017

    Report

    Report Number
    1424643-2017-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Report Date
    January 9, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/21/2017. A SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION; HOWEVER, A PHOTO OF THE REPORTED ISSUE HAS BEEN PROVIDED. BASED ON THE PRINTING OBSERVED IN THE PHOTO, THE HOLE EXISTS AROUND THE 8ML MARK ON THE SYRINGE BARREL. USING THE INCIDENT DESCRIPTION AND THE PICTURE PROVIDED, THE INVESTIGATION TEAM ATTEMPTED TO SIMULATE THE CONDITION OF INCIDENT DESCRIPTION. WHEN DRAWING WATER INTO THE BARREL WITH THE HOLE, THE INVESTIGATION TEAM WAS UNABLE TO RECREATE INCIDENT DESCRIPTION. WATER WAS UNABLE TO BE DRAWN PAST THE HOLE LOCATION WHICH INDICATES THE HOLE WAS NOT FULLY DEVELOPED PRIOR TO DRAWING SOLUTION IN AND PRESSURE BEING APPLIED. THIS INDICATES THAT THE BARREL WALL WAS COMPROMISED AT THE LOCATION OF THE ISSUE PRIOR TO PRESSURE BEING APPLIED BUT WAS INTACT ENOUGH TO STILL ALLOW THE CUSTOMER TO DRAW FLUID BEYOND THE LOCATION OF THE ISSUE. THIS PRESSURE IN CONJUNCTION WITH A COMPROMISED BARREL WALL HAS THE ABILITY TO RESULT IN THE INCIDENT DESCRIPTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A LOT WILL NOT BE RELEASED UNLESS ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS ARE WITHIN ACCEPTABLE LIMITS. ALL DHR¿S ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR DISTRIBUTION. BASED ON THE PRODUCT AND ROOT CAUSE ANALYSIS, THE MOST PROBABLE ROOT CAUSE IS INSUFFICIENT MAINTENANCE PROCESS. DEBRIS WAS LIKELY INTRODUCED DURING MAINTENANCE ACTIVITIES AND CAME IN CONTACT WITH THE PRODUCT AND EQUIPMENT CAUSING UNTYPICAL FORCE TO BE EXERTED ON THE BARREL WALL. BASED ON THE INFORMATION AVAILABLE AND THE INVESTIGATION FINDINGS, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT DEEMED NECESSARY AT THIS TIME AS THIS TIME. STEPS TAKEN IN THIS INVESTIGATION WERE SYNONYMOUS TO THAT OF A PREVIOUS CAPA WHICH INCLUDED UPDATING THE PROCEDURE FOR MANUFACTURING CLEANLINESS. THESE CHANGES ENSURE THAT UPON THE COMPLETION OF PREVENTATIVE AND CORRECTIVE M AINTENANCE WORK, THE TECHNICIAN COMPLETING THE PREVENTIVE MAINTENANCE AND REPAIRS IS RESPONSIBLE FOR COMPLETING A FULL CLEAN-UP OF THE AFFECTED AREA. THE UPDATED PROCEDURE PREVENTS FUTURE INSTANCE OF DAMAGE BEING CREATED AS A RESULT OF DEBRIS INTRODUCED BY MAINTENANCE AND REPAIR. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER REPORTS THAT THE SYRINGE CRACKED AND SPRAYED EVERYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67504 SYR 112 S-PLK SP SYRINGE FMI COVIDIEN 8881112083

    Patients

    Seq Age Sex Outcome Treatment
    1