BEUDAMED
    FDA Adverse Event Summary report: N

    TEMNO NEEDLE BIOPSY COAXIAL 20G X 15CM

    MDR report key: 2854686 · Received December 3, 2012

    Report

    Report Number
    9680904-2012-00047
    Date Received
    December 3, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CAREFUSION
    Product Code
    GDF
    PMA / PMN Number
    K935538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: TWO SAMPLES WERE RECEIVED FOR EVALUATION; BOTH FROM LOT 0000468578. DURING A VISUAL INSPECTION, IT WAS NOTED THAT THE SAMPLES, IDENTIFIED AS SAMPLE #1 AND SAMPLE #2, WERE RECEIVED WITH THE NOTCH (VASCA) BENT. HOWEVER, THE COAXIAL NEEDLE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION OF "STICKING INSIDE THE COAXIAL NEEDLE" COULD NOT BE CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD FOR LOT REPORTED DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. A REVIEW OF APPLICABLE MANUFACTURING, PACKAGING, AND INSPECTION PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE MANUFACTURING AND PACKAGING PROCEDURES REQUIRE THAT A PHYSICAL VERIFICATION OF THE PRODUCT BE PERFORMED PRIOR TO MOVING THE PRODUCT TO THE NEXT MANUFACTURING STAGE. FOR COAXIAL NEEDLES, A FUNCTIONAL VERIFICATION IS ALSO REQUIRED. THE INSPECTION PROCEDURE ALSO REQUIRES FUNCTIONAL TESTS BE PERFORMED PRIOR TO RELEASING THE PRODUCT. NO OPERATOR ERROR WAS IDENTIFIED DURING THE INVESTIGATION THAT COULD RELATE THE OPERATORS TO THE REPORTED CONDITION. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED, AS THE INCIDENT WAS DESCRIBED AS "STICKING INSIDE THE COAXIAL NEEDLE," AND THE COAXIAL NEEDLE WAS NOT RECEIVED FOR APPLICABLE ANALYSIS. ALTHOUGH THE REPORTED CONDITION COULD NOT BE CONFIRMED, APPLICABLE MANUFACTURING LINE PERSONNEL AND QUALITY ASSURANCE INSPECTORS WILL BE MADE AWARE OF THIS REPORT REGARDING THE STICKING COAXIAL NEEDLE CONDITION. THE REPORTED CONDITION WILL ALSO CONTINUE TO BE MONITORED TO IDENTIFY THE NEED FOR ANY FURTHER ACTIONS.

    Description of Event or Problem · 1

    STICKING INSIDE THE COAXIAL NEEDLE. IT ONLY GOES THRU WITH FORCE. ON (B)(6) 2012, THE SALES REPRESENTATIVE ((B)(6)) INDICATED THAT BECAUSE OF THE STICKING "TIGHT TOLERANCE" FIT IN THE COAXIAL CANNULA, THE NEEDLE FROM LOT 0000468578 GOT BENT. ON (B)(6) 2012, THE CUSTOMER ALSO INDICATED THAT THE NEEDLE THAT GOT BENT (LOT 0000468578) AS A RESULT OF THE STICKING "TIGHT TOLERANCE" FIT IN THE COAXIAL CANNULA WAS INVOLVED IN A PATIENT DEVELOPING A PNEUMOTHORAX. THE CUSTOMER HAS 2 SAMPLES FOR EVALUATION, INCLUDING THE NEEDLE THAT GOT BENT. ON (B)(6) 2012, THE CUSTOMER ((B)(6)) INDICATED THAT THE PATIENT WITH THE PNEUMOTHORAX WENT HOME WITH A THORACIC VENT IN PLACE AND RETURNED THE NEXT DAY FOR REMOVAL WITHOUT ANY FURTHER COMPLICATIONS.  NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMNO NEEDLE BIOPSY COAXIAL 20G X 15CM GUIDE, NEEDLE, SURGICAL GDF CAREFUSION CT2015 0000468578

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention