BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 9810734 · Received March 10, 2020

    Report

    Report Number
    1820334-2020-00580
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Report Date
    June 29, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002231627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER BENT AND NEARLY SEPARATED UPON REMOVAL FROM THE PACKAGING. THE INITIAL REPORTER STATED THE DEVICE WAS STUCK INSIDE THE PLASTIC TUBING OF THE PACKAGING MATERIAL, REQUIRING ADDITIONAL FORCE TO REMOVE IT. THE DEVICE DID NOT MAKE PATIENT CONTACT. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE CXI-2.3-14-135-ANG WAS RETURNED PRIOR TO USE. A KINK, MEASURED FROM BOTTOM OF THE STRAIN RELIEF, WAS OBSERVED AT 18CM. THE CATHETER TIP WAS KINKED WITH PARTIAL SEPARATION. THE PARTIALLY SEPARATED SECTION WAS 3MM IN LENGTH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. TWO POTENTIALLY FAILURE-RELATED NON-CONFORMANCES WAS RECORDED. ALL AFFECTED DEVICES WERE IDENTIFIED AND SCRAPPED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. NO GAPS WERE DISCOVERED IN THE MANUFACTURING INSTRUCTIONS OR QUALITY CONTROL PROCEDURES FOR THIS DEVICE. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT IS PACKAGED WITH INSTRUCTIONS FOR USE, WHICH STATE, ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION AVAILABLE, INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THIS EVENT CAN BE TRACED TO A COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. IT IS POSSIBLE THAT THE ADDITIONAL FORCE USED TO REMOVE THE DEVICE FROM THE PLASTIC TUBING COULD HAVE CAUSED THE DEVICE KINK/PARTIAL SEPARATION. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 02JUN2020. THE DEVICE WAS STORED INSIDE A CABINET AT THE USER FACILITY. THE DEVICE PACKAGING WAS NOT OBSERVED TO BE DAMAGED.

    Additional Manufacturer Narrative · 1

    OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K122796. DEVICE EVALUATED BY MFG: DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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

    AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER BENT AND NEARLY SEPARATED UPON REMOVAL FROM THE PACKAGING. THE INITIAL REPORTER STATED THE DEVICE WAS STUCK INSIDE THE PLASTIC TUBING OF THE PACKAGING MATERIAL, REQUIRING ADDITIONAL FORCE TO REMOVE IT. ON RETURN INSPECTION OF THE DEVICE 06MAR2020, THE CATHETER TIP WAS KINKED WITH PARTIAL SEPARATION OF 3MM IN LENGTH. THE DEVICE DID NOT MAKE PATIENT CONTACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274832 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G23162 10264232 00827002231627

    Patients

    Seq Age Sex Outcome Treatment
    1