BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 QT N/S CONTAINER RED 100

    MDR report key: 4408040 · Received January 12, 2015

    Report

    Report Number
    1424643-2015-00002
    Event Type
    Injury
    Date Received
    January 12, 2015
    Date of Event
    November 11, 2014
    Report Date
    November 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS PRODUCT COULD NOT BE CONDUCTED SINCE A LOT NUMBER COULD NOT BE PROVIDED. A REVIEW OF INTERNAL INSPECTION REJECTIONS FOR THIS PARTICULAR ISSUE WAS PERFORMED AND RESULTS SHOWED NO INTERNAL INSPECTION REJECTIONS. A REPRESENTATIVE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THERE HAVE BEEN NO SAMPLES OR PHOTOGRAPHS PROVIDED FOR REVIEW. A REVIEW OF CHANGES TO PRODUCT, PROCESS, AND PACKAGING HAS BEEN CONDUCTED IDENTIFYING NO AFFECTING CHANGES IN THE PREVIOUS 12 MONTHS. THE POTENTIAL ROOT CAUSE FOR THIS TYPE OF ISSUE COULD BE DUE TO EXCESSIVE FORCE APPLIED TO THE SYRINGE WHEN DEPOSITED. PER THE CONTAINER INSTRUCTIONS FOR USE: USING ONE HAND, DROP A SINGLE SYRINGE OR LANCET, POINT DOWN, INTO THE CONTAINER. FORCING, COMPRESSING OR OVERFILLING COULD CAUSE A PUNCTURE WHICH MAY RESULT IN INJURY. BASED ON THE EXISTING CONTROLS, EXAMINATION AND REVIEW OF SIMILAR PRODUCTION SAMPLES, THE INTERNAL REJECT AND THE COMPLAINT HISTORY REVIEW, ADDITIONAL CORRECTION OR CONTAINMENT ACTIVITIES ARE NOT WARRANTED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE INVESTIGATION FINDINGS, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT DEEMED NECESSARY AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH SHARPS CONTAINER. THE CUSTOMER REPORTS AN EMPLOYEE WAS STUCK BY A DIRTY NEEDLE DUE TO THE NEEDLE HAD POKED THROUGH THE SIDE OF THE SHARP CONTAINER. AS A RESULT OF THE NEEDLE STICK, THE EMPLOYEE WENT TO EMPLOYEE CORPORATE HEALTH AND HAD BLOOD DRAWN. THE RESULTS OF THE BLOOD TESTS WERE NEGATIVE. FOLLOW-UP BLOOD TESTS WILL BE DRAWN UP AS PER THE CUSTOMER¿S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26045 1 QT N/S CONTAINER RED 100 SHARPS CONTAINER MMK COVIDIEN 8900SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other