BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL BRUSH BIOPSY SET

    MDR report key: 13193957 · Received January 7, 2022

    Report

    Report Number
    1820334-2022-00029
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Report Date
    January 26, 2022
    Manufacturer
    COOK INC
    Product Code
    FDX
    UDI-DI
    00827002149199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: NON-HEALTHCARE PROFESSIONAL - MATERIAL SUPPLY MANAGER PMA/510(K) NUMBER = K182231. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: IT WAS REPORTED THAT A HAIR-LIKE FOREIGN MATTER WAS NOTED INSIDE A SEALED URETERAL BRUSH BIOPSY SET PACKAGE. THIS WAS NOTED PRIOR TO OPENING AND PRIOR TO PATIENT USE/CONTACT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. THE DEVICE WAS RETURNED TO COOK IN UNOPENED PACKAGING. TWO HAIRS WERE FOUND, ONE HAIR WAS INSIDE THE PACKAGING SEALED AREA, THE OTHER WAS FOUND NEAR THE THUMB HOLE OUTSIDE OF THE SEALED AREA. COOK REVIEWED THE DEVICE HISTORY RECORD AND CONCLUDED THERE ARE NO NON-CONFORMANCES RELATED TO THIS COMPLAINT. A SEARCH OF COMPLIANT HISTORY FOUND NO OTHER COMPLAINTS FOR THE REPORTED LOT. DUE TO THE INDIVIDUAL NATURE OF PACKAGING THE PRODUCT, ONE NON-CONFORMANCE DOES NOT INDICATE ADDITIONAL NON-CONFORMANCES IN THE LOT. THEREFORE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE IS NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. A DEVICE MASTER RECORD REVIEW WAS PERFORMED, INCLUDING QUALITY CONTROL PROCEDURES. CONTROLS WERE FOUND TO BE IN PLACE, THE PACKAGED PRODUCTS ARE VISUALLY INSPECTED PRIOR TO SHIPMENT. COOK HAS CONCLUDED THAT MANUFACTURING CONTRIBUTED TO THE EVENT. THE PACKAGE INSPECTOR FOR THE LOT HAS COMPLETED DEFECT AWARENESS TRAINING IN RESPONSE TO THIS EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR-LIKE FOREIGN MATTER WAS NOTED INSIDE A SEALED URETERAL BRUSH BIOPSY SET PACKAGE. THIS WAS NOTED PRIOR TO OPENING AND PRIOR TO PATIENT USE/CONTACT.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298511 URETERAL BRUSH BIOPSY SET FDX ENDOSCOPIC CYTOLOGY BRUSH FDX COOK INC G14919 14120574 00827002149199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown