BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    MDR report key: 14079624 · Received April 11, 2022

    Report

    Report Number
    1820334-2022-00555
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    February 26, 2022
    Report Date
    July 12, 2022
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002087047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #- K182071. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: H6: MEDICAL DEVICE PROBLEM CODE (ANNEX A) AND COMPONENT CODE (ANNEX G). EVENT DESCRIPTION: AS REPORTED, DURING DELIVERY OF A SOLUTION WITH ACTILYSE, A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET LEAKED FROM THE FITTING WHEN CONNECTED TO A SYRINGE. THE CATHETER WAS FLUSHED WITH SALINE WITH 1ML OF HEPARIN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION: REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL DATA WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE COMPLAINANT PROVIDED PHOTOS OF A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET CATHETER FOR COOK¿S INVESTIGATION. THE IMAGES SHOW THE CATHETER BODY WITH BIOMATTER PRESENT ON THE SHAFT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING AND QUALITY CONTROL DOCUMENTS WAS CONDUCTED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS ENSURE ALL CONNECTIONS ARE SECURE BEFORE USE. DO NOT OVER TIGHTEN AS EXCESSIVE FORCE MAY DAMAGE THE PRODUCT. HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. COOK CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO THE DESIGN OR MANUFACTURING OF THE COMPLAINT DEVICE WAS THE CAUSE OF THIS INCIDENT. ADDITIONALLY, THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND DEVICE MASTER RECORD PROVIDE OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR 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

    AS REPORTED, DURING DELIVERY OF A SOLUTION WITH ACTILYSE, A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET LEAKED FROM THE FITTING WHEN CONNECTED TO A SYRINGE. THE CATHETER WAS FLUSHED WITH SALINE WITH 1ML OF HEPARIN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192237 MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC 13624513 10827002087047

    Patients

    Seq Age Sex Outcome Treatment
    1 Male 10ML BD THREADABLE SYRINGE