BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 8371801 · Received February 26, 2019

    Report

    Report Number
    1820334-2019-00460
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 28, 2019
    Report Date
    April 1, 2019
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002239029
    PMA / PMN Number
    K132885
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: UPDATED (NOT INCLUDED IN INITIAL REPORT). D10 ¿ PRODUCT RECEIVED ON: 28FEB2019. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE NOTED TWO CRACKS OF THE WHITE HUB THAT ARE VISIBLE STARTING FROM THE PROXIMAL END OF THE DEVICE. TOOL MARKINGS SUCH AS HEMOSTATS OR ALLIGATOR CLAMPS ARE NOT VISIBLE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED FOR LOT NUMBER 8232691 AND REVELED NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF SOFTWARE FOUND NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8232691. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. INFORMATION SURROUND THE PATIENT¿S ENVIRONMENT, THE PATIENT¿S PHYSICAL ACTIVITY, THE SUTURING/HUB SECURING PROCESS, AND OTHER DEVICE COMPATIBILITY IS UNKNOWN. THE TORQUE APPLIED WHEN ATTACHING OTHER COMPONENTS IS A PLAUSIBLE CAUSE THAT CONTRIBUTED TO THIS FAILURE, ALTHOUGH NONE OF THESE FACTORS COULD BE CONFIRMED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 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. (B)(4). 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 THE WHITE HUB OF A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC CRACKED. THE PATIENT WAS ADMITTED TO HOSPITAL IN (B)(6) 2018 DUE TO LYMPHOMA, AND A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC WAS PLACED IN THE LEFT ARM. THE PATIENT IMPROVED AND WAS DISCHARGED ON AN UNKNOWN DATE. ON (B)(6) 2019, THE PATIENT HAD A FEVER AND RETURNED TO THE HOSPITAL. THE PHYSICIAN DISCOVERED THAT THE WHITE HUB OF THE TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC WAS CRACKED. THE PHYSICIAN THEN REMOVED THE DEVICE AND PLACED ANOTHER TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC IN THE UPPER LEFT ARM. THE DEVICE WAS FLUSHED WEEKLY WITH SALINE. THE PATIENT ONLY RECEIVED CHEMOTHERAPY THROUGH THIS DEVICE. NO TOOLS WERE USED TO DISCONNECT COMPONENTS FROM THE CRACKED HUB, AND THE ONLY DEVICE CONNECTED TO THE WHITE HUB WAS A 10 MILLILITER INJECTION SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163524 TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 8232691 00827002239029

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention 10ML BD INJECTION SYRINGE