BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE MARROW BIOPSY NDL,

    MDR report key: 2020142 · Received March 16, 2011

    Report

    Report Number
    9680904-2011-00009
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    March 16, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOS OF THE FAILED DEVICES WERE RECEIVED AND THE REPORTED ISSUE WAS CONFIRMED. AN UNOPENED SAMPLE WAS ALSO PROVIDED FOR EVALUATION. MARROW ACQUISITION TEST WAS PERFORMED ON THE UNUSED SAMPLE USING A SYNTHETIC BONE STRUCTURE IN ORDER TO REPRODUCE PRODUCT USE AND NO ISSUES WERE ENCOUNTERED. THE CANNULA DID NOT DETACH FROM THE HANDLE. A PULL TEST WAS ALSO PERFORMED ON THE UNUSED DEVICE TO DETERMINE HOW MUCH FORCE WAS REQUIRED TO REPRODUCE THE REPORTED ISSUE. THE RESULTS WERE FOUND TO BE ACCEPTABLE PER APPLICABLE CRITERIA. VISUAL INSPECTION OF THE DEVICE BOND AREA WAS CONDUCTED AND NO INDICATIONS OF DAMAGE WERE FOUND. THEREFORE, BASED ON THIS INFORMATION WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE ISSUE REPORTED. DURING THE ANALYSIS OF THE MANUFACTURING PROCESS, IT WAS FOUND THAT THE SOLDER PASTE ADHESIVE DISPENSING STEP FOR THE PLACEMENT OF THE LOCK WAS NOT (B)(4), NOT ENSURING THAT THE OPERATOR CONDUCTED THE STEP IN THE SAME MANNER 100% OF THE TIME. THEREFORE, ALLOWING FOR INCONSISTENCY IN THE PRODUCT CONDITION. THIS PROCESS IS COMPLETELY RELIANT ON THE INDIVIDUAL PERSONNEL PERFORMING THE STEP. BASED ON THIS EVALUATION IT IS POSSIBLE THAT DEFICIENCIES IN THE DISPENSING PROCESS FOR THE LOCK-CANNULA BONDING COULD BE A POTENTIAL CAUSE FOR THIS TYPE OF FAILURE. THEREFORE, THE MOST PROBABLE CAUSE FOR THIS INCIDENT CAN BE RELATED TO THE FACT THAT THE DISPENSING PROCESS IS NOT ERROR PROOF. THE DISPENSING PROCESS WILL BE ANALYZED TO DETERMINE OPPORTUNITIES FOR IMPROVEMENTS AND APPLICABLE CHANGES WILL BE MADE AS DETERMINED BY THIS EVALUATION.

    Description of Event or Problem · 1

    DURING A BIOPSY INTERVENTION, THE HANDLE OF THE BK3511 CAME OFF. THEY ARE NOT BROKEN, THERE IS NO SIGN OF DAMAGE. THE CANNULA HAD TO BE TAKEN OUT OF THE PATIENT'S TISSUE WITH A FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MARROW BIOPSY NDL, KIT, NEEDLE, BIOPSY FCG CAREFUSION BK3511 D09020297

    Patients

    Seq Age Sex Outcome Treatment
    1 Other