BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE

    MDR report key: 17646193 · Received August 29, 2023

    Report

    Report Number
    1820334-2023-01170
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    April 28, 2023
    Report Date
    December 6, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002075160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME AND ADDRESS - LINE 2: (B)(6). PHONE: (B)(6). E3: OCCUPATION - REGULATOR AFFAIRS CHIEF. G4: PMA/510(K) # - K182985. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. SUMMARY OF EVENT: AS REPORTED, UPON ARRIVAL AT THE DISTRIBUTION CENTER, TWO ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDES HAD A HAIR LIKE FIBER IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. AN INSPECTION OF UNUSED PRODUCT WAS ALSO CONDUCTED. THE COMPLAINANT RETURNED TWO SEALED DEVICES TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICES FOUND HAIR LIKE FIBERS SEALED INSIDE THE POUCH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES, ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INSPECTION OF THE RETURNED DEVICES SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, THERE IS NO EVIDENCE OF ADDITIONAL NON-CONFORMING PRODUCT IN HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS FAILURE IS A MANUFACTURING AND QUALITY CONTROL DEFICIENCY. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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, UPON ARRIVAL AT THE DISTRIBUTION CENTER, TWO ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDES HAD A HAIR LIKE FIBER IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    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
    1058061 ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC 15226438 00827002075160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown