BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THAL-QUICK CHEST TUBE SET

    MDR report key: 9557886 · Received January 7, 2020

    Report

    Report Number
    1820334-2020-00069
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 11, 2019
    Report Date
    February 25, 2020
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    00827002067875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION-G5: PMA/510(K)= K142829. DESCRIPTION OF EVENT: AS INITIALLY REPORTED, WHILE PREPPING A DEVICE FOR AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH WAS REPORTEDLY FLARED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. INVESTIGATION - EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE FLEXOR ANSEL GUIDING SHEATH WAS RETURNED TO COOK FOR INVESTIGATION. UPON INSPECTING THE DEVICE, NO VISIBLE DAMAGE TO THE SHEATH WAS NOTED, NOR WAS BIO MATTER PRESENT ON THE DEVICE. HOWEVER, SPLIT DAMAGE WAS NOTED TO THE TIP OF THE DILATOR. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE COMPLAINT LOT WAS THUS CONCLUDED TO BE MANUFACTURED TO CURRENT SPECIFICATIONS. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES, ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ GIVEN THE PROVIDED INFORMATION, COOK HAS CONCLUDED THAT A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, POSSIBLE CAUSES FOR THE REPORTED EVENT ARE THE SHIPPING AND HANDLING OF THE DEVICE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: STOREMAN. PMA/510(K) #: EXEMPT. 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 A HAIR WAS NOTICED IN THE UNOPENED PACKAGE OF A THAL-QUICK CHEST TUBE SET. NO PATIENT CONTACT WAS MADE. TO COMPLETE THE PROCEDURE, ANOTHER DRAIN WAS USED. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24147 THAL-QUICK CHEST TUBE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A 9676630 00827002067875

    Patients

    Seq Age Sex Outcome Treatment
    1