BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 7881734 · Received September 17, 2018

    Report

    Report Number
    1820334-2018-02627
    Event Type
    Injury
    Date Received
    September 17, 2018
    Report Date
    December 14, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    PMA / PMN Number
    K132334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 · 0

    DEVICE EVALUATION THE REPORTED USED DEVICE WAS RETURNED TO COOK INC. FOR EVALUATION. VISUAL INSPECTION VERIFIED THE CUSTOMER REPORT OF "STAIN" INSIDE THE LUMEN. A RED DISCOLORATION WAS OBSERVED WITHIN THE LUMEN OF THE PURPLE HUB AND A BROWN SUBSTANCE WAS IDENTIFIED WITHIN THE LUMEN OF THE WHITE HUB. INVESTIGATION A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: INSTRUCTIONS FOR USE, QUALITY CONTROL SPECIFICATIONS AND MANUFACTURING INSTRUCTIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE RISK SPECIFICATION FOR THIS PRODUCT INCLUDES THE LOSS OF USE FAILURE MODE AND IDENTIFIES THE RISK CONTROLS THAT ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE. A COMPLAINT HISTORY SEARCH WAS UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. 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.

    Description of Event or Problem · 0

    THE USED COMPLAINT DEVICE WAS RETURNED TO COOK INC. FOR EVALUATION ON 25OCT2018. THE COMPLAINT DEVICE WAS INITIALLY REPORTED AS A 5FR DOUBLE LUMEN PICC, HOWEVER, THE RETURNED COMPLAINT DEVICE IS A 4FR DOUBLE LUMEN PICC.

    Description of Event or Problem · 0

    SEE H10.

    Additional Manufacturer Narrative · 1

    PATIENT CODE: NO CODE AVAILABLE - THE DEVICE WAS REMOVED AND REPLACED. 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 A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC IMPLANTED IN A HEMATOLOGY PATIENT APPEARED TO HAVE A SMEAR/STAIN ON THE INSIDE OF THE LUMEN. VISUALLY, THE LUMEN APPEARED COMPLETELY BROWN. A CULTURE, TAKEN TWICE A WEEK, WAS NEGATIVE FOR BACTERIA. PHOTOGRAPHS OF THE DEVICE SHOW THE LUMEN APPEARS BROWN/DIRTY. AS REPORTED, THE DEVICE WAS BEING UTILIZED TO DELIVER ANTIBIOTICS AND POTASSIUM CHLORIDE (KCL). THE PATIENT WAS NOT ADVERSELY EFFECTED BY THIS OCCURRENCE AND THE LINE WAS REMOVED AND REPLACED. TO DATE, ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724111 TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention