BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    MDR report key: 18411925 · Received December 28, 2023

    Report

    Report Number
    1820334-2023-01775
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Report Date
    February 9, 2024
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002588318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A - ADDITIONAL COMMON NAME: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION D2B - ADDITIONAL PRODUCT CODE: DRE. E3 - OCCUPATION: CLINICAL VALUE ANALYSIS SPECIALIST. G4 - PMA/510(K) #: K182252. 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: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024. THE CUSTOMER CLARIFIED THAT REPORTED DEVICE WAS NOT DEFECTIVE. THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE. ADDITIONALLY, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY TOOK PLACE, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. 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. THE COMPLAINT WILL BE CLOSE/CANCELLED BY THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CATHETER OF A COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET LEAKED. THE CUSTOMER OBSERVED THE FLUID DRIPPING FROM THE DEVICE WITHOUT REMOVING THE CAP FROM THE LUMEN AND WITHOUT ANY INTERVENTION. IT WAS ALSO NOTED THE DEVICE DID NOT NEED TO BE "PRIMED" DUE TO THIS. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 0

    THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274744 COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A 15188398 00827002588318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown