BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    MDR report key: 9210160 · Received October 18, 2019

    Report

    Report Number
    1820334-2019-02654
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 6, 2019
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002037809
    PMA / PMN Number
    K111244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND TRENDS OF THE DEVICE, AS WELL AS A FUNCTIONAL TEST AND VISUAL INSPECTION OF RETURNED UNUSED PRODUCT FROM THE USER FACILITY WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS ON THE COMPLAINT DEVICE COULD BE PERFORMED. HOWEVER, THE USER FACILITY RETURNED THREE UNOPENED DEVICES FROM THE SAME LOT WITH THE SAME RPN AS THE COMPLAINT DEVICE. FUNCTIONAL TEST OF THESE DEVICES FOUND THAT THEY DO NOT LEAK. CONSEQUENTLY, THE CUSTOMER¿S DIFFICULTY COULD NOT BE RECREATED ON THE RETURNED UNOPENED DEVICES. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY AND 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 REVIEW OF THE DHR FOR THE COMPLAINT LOT (9760506) REVEALED NO NON-CONFORMANCES RELEVANT TO THIS FAILURE MODE. A DATABASE SEARCH FOUND ONE ADDITIONAL COMPLAINT ASSOCIATED WITH THE PROVIDED LOT NUMBER. THAT COMPLAINT WAS OPENED TO ADDRESS A LEAKAGE/HUB ISSUE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, AND THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. BASED ON THE INFORMATION PROVIDED, NO COMPLAINT PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. COOK WILL CONTINUE TO MONITOR 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

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVAL: UNSURE. THE CUSTOMER INITIALLY REPORTED THE CATHETER WOULD BE RETURNED BUT IS NOT ABLE TO CURRENTLY FIND IT. (B)(6). OCCUPATION: UNKNOWN. THE CUSTOMER INITIALLY REPORTED THE CATHETER WOULD BE RETURNED BUT IS NOT ABLE TO CURRENTLY FIND IT. UNSURE IF DEVICE WILL BE RETURNED AND EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POWER INJECTION IN THE ARM, THE PURPLE HUB OF A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC PARTIALLY SEPARATED. THE DEVICE WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019 ONCE THE PARTIAL SEPARATION WAS DISCOVERED, WHICH RESULTED IN PLACEMENT OF A NEW DEVICE. AFTER EXPLANTING AND REVIEWING THE DEVICE, DAMAGE WAS NOTICED WITHIN THE HUB. THE HUB WAS USED APPROXIMATELY 180 TIMES (3 TIMES A DAY) ON AN ACTIVE CHILD BEFORE BEING EXPLANTED. VINCRISTINE (DURING CHEMOTHERAPY) HAD BEEN USED WITH THIS CATHETER. THE DEVICE WAS FLUSHED THROUGH WITH TAUROLOCK. IT HAS ALSO BEEN REPORTED THAT THE DEVICE WAS SECURED TO THE PATIENT AS PER INSTRUCTIONS SUPPLIED WITH THE DEVICE. ADDITIONAL DEVICE STERILIZATION PROCESSES WERE NOT PERFORMED PRIOR TO USE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004235 TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 9760506 00827002037809

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention