BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT POWER INJECTABLE

    MDR report key: 7659287 · Received July 3, 2018

    Report

    Report Number
    1820334-2018-01900
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 14, 2018
    Report Date
    October 16, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002561946
    PMA / PMN Number
    K111244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION HAS PREVIOUSLY BEEN REPORTED, IS UNKNOWN OR IS UNAVAILABLE. THE COMPLAINT DEVICE WAS RETURNED ON (B)(6) 2018 AND EVALUATED ON (B)(6) 2018. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2018 AND REVIEWED ON (B)(6) 2018. THE RETURNED USED DEVICE MET SPECIFICATION AND DID NOT SHOW SIGNS OF FRAYING, UNRAVELING, OR FRAGMENTATION/SEPARATION. THIS COMPLAINT NO LONGER MEETS THE FDA 21 CFR PART 803 DEFINITION OF A DEVICE MALFUNCTION. 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

    SEE H10.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K111244. 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 THE WIRE WOULD NOT PULL OUR OF THE CATHETER AFTER A TURBO-JECT POWER INJECTABLE PICC LINE WAS INSERTED. THE PATIENT WAS SAID TO HAVE ANGULATED AND TORTUOUS VESSELS. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501521 TURBO-JECT POWER INJECTABLE LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC G56194 8616147 00827002561946

    Patients

    Seq Age Sex Outcome Treatment
    1