BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER

    MDR report key: 7136341 · Received December 20, 2017

    Report

    Report Number
    1820334-2017-04619
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    December 14, 2017
    Report Date
    April 19, 2018
    Manufacturer
    COOK INC
    Product Code
    DQO
    UDI-DI
    00827002094062
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. ONE, USED BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER (HNR4.0-35-70-P-10S-PIG) WAS RETURNED FOR EXAMINATION. A SEGMENT 1.0MM WIDE BY 0.5MM LENGTH IS MISSING FROM THE DISTAL TIP. THERE WERE NO OTHER NON-CONFORMITIES NOTED ON THE CATHETER. IT WAS NOTED THAT THE PRODUCT WAS MANUFACTURED ON 01JUN2014 AND IS SUPPOSED TO BE EXPIRED ON 01JUN2017, YET WAS UTILIZED FOR A PROCEDURE ON 14DEC2017. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE DEFINITIVE ROOT CAUSE IS A COMBINED MANUFACTURING PROCESS (BONDING PREPARATION, CURVING) AND ENVIRONMENTAL PROBLEM (VHP, ELEVATED TEMPERATURE AND HUMIDITY) . APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THESE FAILURE MODES. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. ONE, USED BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER (HNR4.0-35-70-P-10S-PIG) WAS RETURNED FOR EXAMINATION. A SEGMENT 1.0MM WIDE BY 0.5MM LENGTH IS MISSING FROM THE DISTAL TIP. THERE WERE NO OTHER NON-CONFORMITIES NOTED ON THE CATHETER. IT WAS NOTED THAT THE PRODUCT WAS MANUFACTURED ON 01JUN2014 AND IS SUPPOSED TO BE EXPIRED ON 01JUN2017, YET WAS UTILIZED FOR A PROCEDURE ON 14DEC2017. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE DEFINITIVE ROOT CAUSE IS A COMBINED MANUFACTURING PROCESS (BONDING PREPARATION, CURVING) AND ENVIRONMENTAL PROBLEM (VHP, ELEVATED TEMPERATURE AND HUMIDITY) . APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THESE FAILURE MODES. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AORTIC ARCH RUNOFF AND ABDOMINAL AORTIC RUNOFF PROCEDURE, THE BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER MIDDLE PORTION OF TIP CAME OFF INSIDE OF THE PATIENT'S ANATOMY. THE CATHETER TIP WAS ABLE TO BE RETRIEVED ENDOVASCULARLY USING A SNARE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914538 BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC 00827002094062

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention