BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8129969 · Received December 4, 2018

    Report

    Report Number
    1820334-2018-03511
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 19, 2018
    Report Date
    December 11, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPH WAS PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS. A REVIEW OF THE DEVICE HISTORY OBSERVED NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9229923. THIS DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH CONTAINS THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. A CONCLUSION AS TO THE CAUSE OF THE REPORTED ISSUE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. 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. 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

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K170622. (B)(4). 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 INITIALLY REPORTED, THE BAKRI TAMPONADE BALLOON HAD A HOLE IN IT AND COULD NOT INFLATE PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. THE BAKRI HAD HOLE IN IT UPON REMOVAL FROM PACKAGING AND THEREFORE WOULD NOT INFLATE. THEY HAVE DISCARDED THE ITEM AND USED ANOTHER. THE DEVICE WAS USED POST-DELIVERY TO REDUCE RISK ASSOCIATED WITH POSTPARTUM HEMORRHAGE (PPH). A SECOND BAKRI WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969800 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 9229923 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1