BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7480712 · Received May 2, 2018

    Report

    Report Number
    1820334-2018-01285
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    December 9, 2017
    Report Date
    June 11, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION THE RETURNED DEVICE WAS PERFORMED. THE INVESTIGATION ALSO INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS, AND TRENDS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTED A CUT IN THE BALLOON MATERIAL IN THE PROXIMAL END OF THE BALLOON. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8142541. THE INSTRUCTIONS FOR USE (IFU), STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. THE USER IS ADVISED, 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 INSPECTED VISUALLY AND FUNCTIONALLY AT THE SUPPLIER FOR LEAKS, INFLATION AND DEFLATION. THE REPORTED LEAK IN THE BALLOON MATERIAL WAS CONFIRMED. A SMALL CUT WAS NOTED AS THE SOURCE OF THE LEAK HOWEVER THE SOURCE OF THE CUT COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION THE RETURNED DEVICE WAS PERFORMED. THE INVESTIGATION ALSO INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS, AND TRENDS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTED A CUT IN THE BALLOON MATERIAL IN THE PROXIMAL END OF THE BALLOON. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8142541. THE INSTRUCTIONS FOR USE (IFU), STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. THE USER IS ADVISED, 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 INSPECTED VISUALLY AND FUNCTIONALLY AT THE SUPPLIER FOR LEAKS, INFLATION AND DEFLATION. THE REPORTED LEAK IN THE BALLOON MATERIAL WAS CONFIRMED. A SMALL CUT WAS NOTED AS THE SOURCE OF THE LEAK HOWEVER THE SOURCE OF THE CUT COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (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 THE USER INJECTED WATER INTO THE BAKRI TAMPONADE BALLOON CATHETER BUT THE WATER LEAKED FROM A HOLE IN THE BALLOON MATERIAL PRIOR TO THE PATIENT CONTACT. ANOTHER BAKRI TAMPONADE BALLOON CATHETER WAS USED INSTEAD FOR THE PROCEDURE. 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
    323276 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1