BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVER ACCESS AND BIOPSY SET

    MDR report key: 12346027 · Received August 19, 2021

    Report

    Report Number
    1820334-2021-02026
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 15, 2021
    Report Date
    July 14, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002574854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: (B)(6) HOSPITAL (UNITED STATES) INFORMED COOK ON 20JUL2021 OF AN INCIDENT INVOLVING A LABS-100-J-01 (LIVER ACCESS AND BIOPSY SET) FROM LOT 13589436. IT WAS REPORTED THAT THE TOP OF THE CATHETER BROKE, WITH THE DISTAL PORTION ALSO DAMAGED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT THAT WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL, AND THE INSTRUCTIONS FOR USE (IFU), AS WELL AS INTERVIEWS WITH PERSONNEL AND A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED DEVICE WAS RECEIVED; THE FLARE CAME OUT OF THE 5FR HUB ON THE BLACK TUBING. BUNCHING OF THE BLACK MATERIAL WAS NOTED AT APPROXIMATELY 6.7 FROM THE DISTAL TIP AND WAS APPROXIMATELY 4MM IN LENGTH. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (1358943 ) REVEALED NO NON-CONFORMANCES. A REVIEW OF THE RELATED SUBASSEMBLY LOTS IC13417823 AND IC13498993 REVEALED POSSIBLE RELATED NONCONFORMANCES; HOWEVER, ALL PRODUCT WAS CHECKED 100% AND ALL NONCONFORMING PRODUCTS WERE SCRAPPED. THERE ARE NO ADDITIONAL COMPLAINTS ON LOT 13589436. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [T_LABS2_REV1] STATE THE FOLLOWING: "WARNINGS EXTREME CARE MUST BE EXERCISED DURING MANIPULATION AND WITHDRAWAL OF CATHETER TO PREVENT PULLING CATHETER APART. HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. 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

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

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: HVC INVENTORY CONTROL LEAD. REPORT SOURCE - OTHER: MEDWATCH: (B)(4). PMA/510(K) #: K171853. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAMAGE WAS OBSERVED ON THE PROXIMAL AND DISTAL PORTIONS OF A LIVER ACCESS AND BIOPSY SET CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT OR HARM. UPON REMOVAL, THE CATHETER WAS NOTED TO BE FRAYED AND THE LUER LOCK PORTION AT THE TOP HAD FALLEN OFF. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER ON 11AUG2021. A VISUAL INSPECTION CONFIRMED THAT THE 5FR STRAIGHT BLACK CATHETER HAD A DAMAGED/BUNCHED TIP AND THE HUB OF THE DEVICE WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240494 LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 13589436 00827002574854

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female