BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    MDR report key: 9209954 · Received October 18, 2019

    Report

    Report Number
    1820334-2019-02652
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 25, 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, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. VISUAL EXAMINATION NOTED THAT THE CATHETER WAS RETURNED ALONG WITH A 10 ML SYRINGE FILLED WITH FLUSHING LIQUID AND TWO LOOSE FITTINGS. THE PURPLE HUB WAS NOTED TO BE PARTIALLY SEPARATED FROM THE CLEAR TUBING. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS COMPLETED. 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 RELATED NON-CONFORMANCES. A DATABASE SEARCH FOUND ONE OTHER COMPLAINT ASSOCIATED WITH THE GIVEN DEVICE LOT THAT WAS OPENED FOR A HUB SEPARATION ISSUE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, 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, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES ARE BEING TAKEN TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: UNKNOWN. 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 THAT DURING A BLOOD WITHDRAWAL IN THE ARM ON (B)(6) 2019, THERE WAS A LEAKAGE AT THE JUNCTION OF THE PURPLE HUB AND LUMEN OF A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC DEVICE. THE DEVICE WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ONCE THE LEAKAGE WAS DISCOVERED, WHICH RESULTED IN THE PLACEMENT OF A NEW DEVICE. THE HUB WAS USED APPROXIMATELY 135 TIMES IN A VERY ACTIVE CHILD BEFORE BEING EXPLANTED. TAXOCIN AND CYTARABIN HAD BEEN USED WITH THIS CATHETER. THE DEVICE WAS FLUSHED THROUGH WITH TAUROLOCK. IT HAS 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
    1003259 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 2 YR Required Intervention