BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NS-151 FINE TIP SKIN MARKER

    MDR report key: 6102278 · Received November 15, 2016

    Report

    Report Number
    9612030-2016-00651
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Report Date
    November 9, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/15/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. THE PICTURES OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE CUSTOMER STATED THAT NINE MARKERS WERE LEAKING. THE REPORTED CONDITION WAS CONFIRMED DURING THE INSPECTION. THE SAMPLE WAS ANALYSED BY THE PICTURES WHICH SHOWED THAT THE REPORTED CONDITION APPEARS TO BE A LEAK IN THE COMPONENT (SKIN MARKER). THE REVIEW OF DEVICE HISTORY RECORD (DHR) INDICATED THAT NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE DEFECT DESCRIBED BY THE CUSTOMER. THE DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT DURING THE PRODUCTION PROCESS ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS. THE RETURNED SAMPLE DID NOT MEET THE QUALITY REQUIREMENT SPECIFICATIONS. THE POSSIBLE ROOT CAUSE FOR LEAKAGE FROM THE AIR HOLE AS PROVIDED BY THE MANUFACTURER MAY BE SHOCK TO THE MARKER BY DROPPING IT, DECOMPRESSION (EOG STERILIZATION). AFTER A FORMAL INVESTIGATION OF THE RETURNED SAMPLE THE ROOT CAUSE WAS INDICATED AS SHOCK TO THE MARKER WHEN DROPPING IT. AS A CORRECTIVE ACTION, THE LOGISTIC DEPARTMENT WAS ADVISED TO HANDLE THE PRODUCT WITH CARE AFTER THE PRODUCT IS NOT PALLETIZED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SKIN MARKER. THE CUSTOMER STATES THAT NINE MARKERS WERE LEAKING. THIS WAS FOUND DURING INCOMING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753162 NS-151 FINE TIP SKIN MARKER SKIN MARKERS FZZ COVIDIEN 31160545 6257112664

    Patients

    Seq Age Sex Outcome Treatment
    1