BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 QT N/A CONTAINER RED 100

    MDR report key: 4046933 · Received August 22, 2014

    Report

    Report Number
    1424643-2014-00009
    Event Type
    Injury
    Date Received
    August 22, 2014
    Report Date
    August 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD DATA HAS BEEN CONDUCTED ON LOT NUMBER 157783 WHICH HAS SHOWN NO NONCONFORMING EVENTS WITH THE POTENTIAL TO LEAD TO THIS COMPLAINT. A REVIEW OF INTERNAL INSPECTION REJECTIONS FOR THIS PARTICULAR ISSUE FOR FINISHED GOOD (B)(4) WAS PERFORMED AND RESULTS SHOWED NO INTERNAL INSPECTION REJECTIONS. BASED ON THE PHOTOGRAPHS PROVIDED, REVIEW OF THIS SAMPLE HAS SHOWN: THE NEEDLE WAS FOUND PENETRATING THE REAR PANEL ON THE LOWER HALF OF THE CONTAINER. THE CONTAINER FILL LEVEL COULD NOT BE DETERMINED. THE FORCE REQUIRED TO PASS THE PENETRATING NEEDLE THROUGH A SIMILAR CONTAINER FROM THE SAME LOT MEETS ALL ACCEPTANCE CRITERIA. THE WALL THICKNESS FOR A SIMILAR CONTAINER FROM THE SAME LOT WAS WITHIN ACCEPTABLE RANGE. A REVIEW OF CHANGES TO PRODUCT, PROCESS, AND PACKAGING HAS BEEN CONDUCTED IDENTIFYING NO AFFECTING CHANGES IN THE PREVIOUS 12 MONTHS. WITH THE INFORMATION CURRENTLY AVAILABLE, FAILURE TO FOLLOW DOCUMENTED INSTRUCTIONS FOR USE COULD CAUSE THE REPORTED EVENT. THE ROOT CAUSE ASSOCIATED WITH THIS EVENT HAS BEEN IDENTIFIED AS EXCESSIVE FORCE APPLIED TO THE SHARP, WHICH CAUSED PENETRATION THROUGH THE CONTAINER WALL. BASED ON THE EXISTING CONTROLS, EXAMINATION AND TESTING OF THE PRODUCT, THE INTERNAL REJECTION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER RECEIVED A NEEDLE STICK. THE CUSTOMER REPORTS THE CONTAINER CONTAINED NEEDLES THAT HAD BEEN DISPOSED OF AND ONE PROTRUDED THROUGH THE PLASTIC OF THE CONTAINER AND POKED A SUPPLY CLERK. THE CUSTOMER REPORTED THE NEEDLE PUNCTURED THE CONTAINER AT APPROX THE HALFWAY MARK OF THE CONTAINER. THE EMPLOYEE IMMEDIATELY WASHED THE AREA WITH SOAPY WATER AND THEN WAS SENT TO THE URGENT CARE CENTER WHERE THEY CONDUCTED BLOOD TESTS AND INITIATED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510285 1 QT N/A CONTAINER RED 100 SHARPS CONTAINER MMK COVIDIEN 8900SA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other