BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK V. MUELLER

    MDR report key: 3701317 · Received March 26, 2014

    Report

    Report Number
    1038548-2014-00036
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 26, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FURTHER INFORMATION WAS OBTAINED BY THE SALES REP DURING HIS VISIT TO THE FACILITY ON (B)(6) 2014. THE SALES REP REPORTED THAT THERE WERE FOUR (4) TEBBETTS RETRACTORS USED IN THE CASE, WHICH IS TWO (2) MORE THEN ORIGINALLY REPORTED BY THE CUSTOMER. THE LOT NUMBERS AND PRODUCT NUMBERS WERE UNKNOWN. THE HOSPITAL COULD NOT IDENTIFY WHICH OF THE FOUR TEBBETTS RETRACTOR WAS USED IN THE CASE. NO PHOTOS WERE TAKEN OF THE TEBBETTS RETRACTORS. THE BIO MED MANAGER TESTED ALL FOUR OF THE RETRACTORS AND DID NOT FIND ANY ISSUES. THE SALES REP WAS ABLE TO TAKE PICTURES OF THE LIGHT CABLE (PRODUCT CODE (B)(4),LOT NUMBER 833502) LISTED IN CASE (B)(4) WHOS INVESTIGATION CONCLUDED CREATED THE FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DAMAGED PRODUCT MEDWATCH (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER (B)(4) 2014. THE CUSTOMER STATED THAT OUR TEBBETTS RETRACTORS WERE ATTACHED TO THE LIGHT SOURCE WHEN THE LIGHT SOURCE FRAYED AND FELL INTO THE PATIENT'S OPEN BREAST. HE DID NOT BELIEVE THERE WAS ANY PATIENT HARM. HE STATED HE HAD NO FURTHER INFORMATION AT THIS TIME. HE STATED THAT THE INSTRUMENTS WOULD NOT BE SENT FOR EVALUATION BUT DID OFFER TO ALLOW US TO COME TO THE FACILITY TO EVALUATED DURING A CUSTOMER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178057 UNK V. MUELLER RETRACTOR, FIBEROPTIC FDG CAREFUSION UNK V. MUELLER

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other