BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED NOVY CORNUAL CANNULATION SET

    MDR report key: 20757577 · Received November 22, 2024

    Report

    Report Number
    1820334-2024-01535
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 20, 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

    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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: B1, H1: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. AS SUCH, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT; NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED. CORRECTED INFORMATION: H6: ANNEX A. THE DEVICE WAS RECEIVED 04DEC2024: YELLOW TINT IS VISIBLE ON CHEVRON END OF PACKAGE. APPEARS THE PACKAGE WAS EXPOSED TO LIGHT FOR LONG PERIODS OF TIME. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR PATIENT DEATH. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. 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, THE MODIFIED NOVY CORNUAL CANNULATION SET POUCH WAS VISIBLY YELLOW (FOREIGN MATTER IS IDENTIFIED WITHIN THE DEVICE OR PACKAGING), THIS ISSUE WAS DISCOVERED PRIOR TO PACKAGE BEING OPENED AND IT WAS NOT USED ON A PATIENT. THE INITIAL REPORTER BELIEVED THE DEVICE MAY HAVE BEEN CONTAMINATED DUE TO YELLOW POUCH AND OPTED NOT TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797790 MODIFIED NOVY CORNUAL CANNULATION SET MOV CATHETER, SALPINGOGRAPHY MOV COOK INC G17558 15217711 00827002175587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown