BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED NOVY CORNUAL CANNULATION SET

    MDR report key: 18489295 · Received January 10, 2024

    Report

    Report Number
    1820334-2024-00057
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 11, 2023
    Report Date
    February 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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. EVENT SUMMARY AS REPORTED, PRIOR TO USE, A HAIR WAS FOUND INSIDE THE PACKAGING OF A MODIFIED NOVY CORNUAL CANNULATION SET. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE WERE CONDUCTED. ONE MODIFIED NOVY CORNUAL CANNULATION SET WAS RETURNED TO COOK FOR EVALUATION IN PARTIALLY OPENED PACKAGING. A HAIR IN WAS OBSERVED IN THE PACKAGE. 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 DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. ADDITIONALLY, THERE HAVE BEEN NO OTHER COMPLAINTS FILED FOR THIS LOT. THEREFORE, THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING PRODUCT ARE IN THE FIELD. THE IFU SUPPLIED WITH THE DEVICE, J-NCS-504070, WAS REVIEWED AND INCLUDES THE FOLLOWING HOW SUPPLIED DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THE CAUSE OF THE COMPLAINT IS MANUFACTURING. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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, PRIOR TO USE, A HAIR WAS FOUND INSIDE THE PACKAGING OF A MODIFIED NOVY CORNUAL CANNULATION SET. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR 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 THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645065 MODIFIED NOVY CORNUAL CANNULATION SET MOV CATHETER, SALPINGOGRAPHY MOV COOK INC 14617737 00827002175587

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female