BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Catheter, intravascular, therapeutic, short-term less than 30 days

    MDR report key: 15770034 · Received November 10, 2022

    Report

    Report Number
    1820334-2022-01716
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    November 3, 2022
    Report Date
    February 2, 2023
    Manufacturer
    COOK INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NAME: COOK SPECTRUM MINOCYCLINE / RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET THESE FIELDS ARE UNAVAILABLE FOR THIS DEVICE AS IT IS NOT SOLD IN THE U.S.; HOWEVER, THIS DEVICE MEETS THE QUALIFICATIONS FOR A DEVICE THAT IS SAME/SIMILAR TO ONE THAT IS SOLD IN THE U.S., THUS PROMPTING THIS REPORT. DATA FOR THE LIKE DEVICE IS AS FOLLOWS: COMMON NAME: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS. PRODUCT CODE: FOZ. PMA/510(K) #: K081113. (B)(6). OCCUPATION: RIGHT HEART CATHETER AND CARDIAC BIOPSY NURSE COORDINATOR. 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

    TWO OPENED, UNUSED DEVICES AND THREE SEALED DEVICES WERE RECEIVED BY COOK ON 05DEC2022. UPON INSPECTION OF THE RETURN OF DEVICES, THE SIDE PORTS WERE DETERMINED TO BE WITHIN SPECIFICATION. NO PORTION OF THE CATHETER WAS CHIPPED AWAY. THEREFORE, THERE IS NO EVIDENCE TO SUGGEST THAT THE COOK DEVICE FAILED TO PERFORM AS INTENDED IN THIS EVENT. FURTHERMORE, 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 WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THIS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE CATHETERS IN COOK SPECTRUM MINOCYCLINE / RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SETS WERE TORN. DURING THE INSERTION OF THE CENTRAL VENOUS CATHETER (CVC), THE CUSTOMER OBSERVED ONE OF THE SIDE PORTS ON THE CATHETER WAS DIFFERENT. UPON FURTHER INSPECTION, IT WAS NOTED A PIECE OF THE CATHETER SHAFT HAD TORN AWAY. ANOTHER DEVICE FROM THE SAME LOT WAS OPENED, BUT IT HAD THE SAME ISSUE. THE PROCEDURE WAS THEN COMPLETED WITH A LIKE DEVICE FROM A DIFFERENT LOT NUMBER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. IT WAS NOTED THE CUSTOMER FOUND THREE MORE DEVICES FROM THE COMPLAINT LOT NUMBER WITH THE SAME ISSUE.

    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
    1060041 Catheter, intravascular, therapeutic, short-term less than 30 days FOZ COOK INC N/A 14623376

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown