BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED NOVY CORNUAL CANNULATION SET

    MDR report key: 18908843 · Received March 14, 2024

    Report

    Report Number
    1820334-2024-00355
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 23, 2024
    Report Date
    September 19, 2024
    Manufacturer
    COOK INC
    Product Code
    MOV
    UDI-DI
    00827002175587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: CUSTOMER (PERSON) STREET = A-4-2602 TONGCHENG PLAZA ANSONGYUAN ROAD / POSTAL CODE = 430022 E3: CUSTOMER OCCUPATION = UNKNOWN G4: PMA/510(K) # = K180552 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: D4: MODEL # = GPN # INVESTIGATION - EVALUATION AS REPORTED, BLACK FOREIGN MATTER WAS FOUND IN AN UNOPENED 'MODIFIED NOVY CORNUAL CANNULATION SET' PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. ONE AREA WAS MARKED BY CUSTOMER HOWEVER THE FOREIGN MATTER MUST HAVE SHIFTED AS IT WAS NO LONGER VISIBLE. OTHER SMALL FRAGMENTS OF UNKNOWN ORIGIN WERE FOUND INSIDE THE STERILE BARRIER. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND RELATED NON-CONFORMANCES REPORTED FOR LOT, THE NON-CONFORMING PRODUCTS WERE REWORKED PRIOR TO SHIPMENT. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. WHILE THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATION, BECAUSE THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING; THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: HOW SUPPLIED SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THE COMPLAINT WAS CONFIRMED BY THE RETURNED UNOPENED PRODUCT. BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT WAS A QUALITY CONTROL DEFICIENCY; A DEFECT AWARENESS FORM WAS COMPLETED BY ONE OF TWO PACKAGED DEVICE INSPECTORS AND THE DEPARTMENT SUPERVISOR. 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

    AS REPORTED, BLACK FOREIGN MATTER WAS FOUND IN AN UNOPENED 'MODIFIED NOVY CORNUAL CANNULATION SET' PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THEPREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163174 MODIFIED NOVY CORNUAL CANNULATION SET MOV CATHETER, SALPINGOGRAPHY MOV COOK INC G17558 15152619 00827002175587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown