BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7489942 · Received May 7, 2018

    Report

    Report Number
    1820334-2018-01396
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 26, 2018
    Report Date
    June 11, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. THE INVESTIGATION ALSO INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, SPECIFICATIONS, AND TRENDS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED AND A PIN HOLE LEAK WAS NOTED IN THE BALLOON MATERIAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7837272. THE INSTRUCTIONS FOR USE (IFU), STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. WARNING: ALWAYS INFLATE THE BALLOON WITH STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. HOW SUPPLIED: STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THIS DEVICE IS 100% INSPECTED VISUALLY FOR SURFACE IMPERFECTIONS AND FUNCTIONALLY TESTED FOR LEAKS, INFLATION, AND DEFLATION. THE DEVICE EVALUATION CONFIRMED THE PRESENCE OF THE PINHOLE LEAK HOWEVER, THE CAUSE OF THE PINHOLE WAS UNABLE TO BE DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    COMMON NAME: INTRAUTERINE TAMPONADE BALLOON PRODUCT CODE: OQY (B)(4). PMA/510(K) #: K170622. 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 PRIOR TO PATIENT CONTACT, THE USER DID A TEST WHERE THEY INJECTED 50ML OF WATER INTO THE BAKRI TAMPONADE BALLOON CATHETER AND FOUND THAT THE BALLOON HAD A PIN HOLE LEAK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332193 BAKRI TAMPONADE BALLOON CATHETER OQY COOK INC 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1