BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 6918157 · Received October 5, 2017

    Report

    Report Number
    1820334-2017-03438
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 20, 2017
    Report Date
    March 6, 2018
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002039544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED OPENED AND UNUSED. A VISUAL EXAMINATION NOTED A BLACK, FREE FLOATING SINGLE STRAND OF FIBER INSIDE THE STERILE PACKAGING. NO OTHER DEFECTS WERE NOTED IN THE PACKAGING. THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED AND IT WAS FOUND THAT THE PACKAGING WAS VISUALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE IDENTIFIED. THE RISK SPECIFICATION FOR THIS PRODUCT INCLUDES THE FAILURE MODE FOR PACKAGING NOT KEEPING THE DEVICE STERILE AND BIOBURDEN ON DEVICE DUE TO ENVIRONMENTAL CONTAMINATION AND IDENTIFIES THAT MULTIPLE RISK CONTROLS ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED WITH LOT 7722541. A SEARCH OF OUR COMPLAINT RECORDS INDICATES THAT THIS IS THE ONLY COMPLAINT ASSOCIATED TO THE COMPLAINT LOT 7722541. THE COMPLAINT HAS BEEN CONFIRMED BASED ON CUSTOMER TESTIMONY AND EXAMINATION OF THE RETURNED DEVICE. THE ROOT CAUSE OF THIS EVENT IS MANUFACTURING RELATED - FOREIGN MATTER. PER THE CONCLUSION OF THE RISK ASSESSMENT FOR FOREIGN MATTER, NO RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    PROCODE: MJG. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, DURING AN INSPECTION OF THE CHIBA BIOPSY NEEDLE WHICH OCCURRED PRIOR TO USE, A HAIR WAS VISIBLE THROUGH THE PRODUCT PACKAGING. THE PACKAGE WAS REPORTEDLY NOT USED ON A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS OCCURRED. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698661 CHIBA BIOPSY NEEDLE KNW COOK INC N/A 00827002039544

    Patients

    Seq Age Sex Outcome Treatment
    1