BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIBA NEEDLE SETS COAXIAL 22G X20CM 5/CS

    MDR report key: 1755928 · Received July 7, 2010

    Report

    Report Number
    9680904-2010-00012
    Event Type
    Malfunction
    Date Received
    July 7, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 6, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    Removal / Correction Number
    9860904-06/25/10-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT PROVIDED BY THE CUSTOMER FOR FURTHER CAREFUSION EVALUATION, HOWEVER, THE REPORTED DEFECT WAS CONFIRMED DURING A FINISHED GOOD INVENTORY INSPECTION FOR THE REPORTED LOT NUMBER WITHIN THE CAREFUSION DISTRIBUTION CENTER. IMMEDIATE STEPS WERE TAKEN TO EXPEDITIOUSLY QUARANTINE ALL FINISHED GOOD INVENTORY FOR THE REPORTED LOT NUMBER WITH THE CAREFUSION DISTRIBUTION CENTER. ADDITIONALLY, A THOROUGH HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED AND IT WAS DETERMINED THAT A PRODUCT RECALL FOR THE REPORTED LOT NUMBER WAS WARRANTED GIVEN THE POTENTIAL HEALTH RISK OF THE REPORTED DEFECT. A VOLUNTARY PRODUCT RECALL WAS INITIATED ON (B)(4) 2010 (REFERENCE RECALL REPORT NUMBER 9860904-06/25/10-R). FORMAL CORRECTIVE/PREVENTIVE ACTION (CAPA-IS/DR/55) HAS BEEN INITIATED. A TOTAL OF TWO (2) PRODUCT QUALITY REPORTS HAVE BEEN RECEIVED TO-DATE RELATED TO THE REPORTED DEFECT AND REPORTED LOT NUMBER. NO PATIENT INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE LONG NEEDLE IS THE INCORRECT SIZE. IT SHOULD BE 15CM AND IT IS ONLY 10 CM. "THIS COULD CAUSE THE DOCTOR TO GO TOO DEEP INTO THE LUNG WHILE PERFORMING THE LUNG BIOPSY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIBA NEEDLE SETS COAXIAL 22G X20CM 5/CS CHIBA NEEDLE SETS COAXIAL 22G X20CM 5/CS FCG CAREFUSION CCH2220 D09121745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other