BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 7734427 · Received July 31, 2018

    Report

    Report Number
    1820334-2018-02341
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 5, 2018
    Report Date
    August 24, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K # K170622. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED, AND IT WAS NOTED THAT WHEN FLUID WAS INSERTED INTO THE BALLOON LUMEN, FLUID BACKFLOW OUT OF THE OTHER LUMEN, INDICATING LUMEN COMMUNICATION. THE LUMEN COMMUNICATION IS PREVENTING THE BALLOON FROM INFLATING PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 8562164. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THIS PRODUCT IS 100 % LEAK TESTED. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. THE CONCLUSION FOR THIS DEVICE ISSUE HAS BEEN TRACED TO COMPONENT FAILURE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED, "IN A SIMULATION THE BALL OF THE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS COULD NOT BE INSUFFLATED. THE FISSURE IS IN THE INTERNAL CATHETER." NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 31JUL2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578695 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 8562164 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1