BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM TURBO-JECT

    MDR report key: 7314092 · Received March 5, 2018

    Report

    Report Number
    1820334-2018-00429
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Report Date
    May 22, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002239166
    PMA / PMN Number
    K133634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    . INVESTIGATION: EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED, HOWEVER A DEVICE FROM THE SAME LOT: (8232646) THAT HAD NOT BEEN RELEASED WAS PULLED FROM NADC FOR TABLE TOP TESTING. UPON INSPECTION, THE DWGO-13SP-81-HAS-LL-HC WIRE THAT COMES INSERTED INTO THE CATHETER WAS INITIALLY DIFFICULT TO REMOVE AND IT APPEARED TO BE STICKING AT THE DISTAL END OF THE CATHETER. HOWEVER WHILE HOLDING THE DISTAL END OF THE CATHETER STRAIGHT THE DWGO WAS ABLE TO BE REMOVED. DUE TO THE HC COATING ON THE WIRE IT IS LIKELY THAT THE DEVICE BEING MANIPULATED WITHOUT GLOVES AND NOT IN A MORE CONTROLLED ENVIRONMENT LED TO THIS DIFFICULTY. AFTER THE REMOVAL OF THE DWGO, THE CATHETER WAS PLACED OVER THE THTF-18SP-130-AUST-ST WIRE GUIDE AS INSTRUCTED IN THE IFU. THIS WAS DONE WITHOUT DIFFICULTY, AND THE WIRE GUIDE WAS REMOVED FROM THE CATHETER WITHOUT ISSUE. THIS WAS DONE WITH THE SECOND LUMEN OF THE CATHETER, ALSO WITHOUT DIFFICULTY. THE FAILURE WAS NOT ABLE TO BE REPLICATED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPONENT WORK ORDERS SHOW NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER: (8232646). BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A POSSIBLE ROOT CAUSE OF THIS FAILURE COULD BE USE TECHNIQUE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE PROVIDED IFU. IT IS POSSIBLE THAT DURING THE PROCEDURE, THE CATHETER WAS IN A POSITION THAT COMPROMISED THE ABILITY OF THE WIRE TO BE REMOVED, OR SOMETHING HAPPENED WITH THE WIRE GUIDE WHILE IT WAS IN USE THAT MADE IT DIFFICULT TO REMOVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND WILL NOTIFY APPROPRIATE PERSONNEL. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 · 1

    BRAND NAME: TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN OVER-THE-WIRE POWER-INJECTABLE PICC. (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

    THE CUSTOMER REPORTED THAT, WHEN THE USER ATTEMPTS TO REMOVE THE SUPPLIED WIRE GUIDE FROM THE TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN OVER-THE-WIRE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE DURING A PROCEDURE, THE WIRES STICK. CAUSING DIFFICULTY BEING REMOVED. EVENTUALLY THEY ARE ABLE TO REMOVE THE WIRE SUCCESSFULLY. A COMPETITOR'S WIRE WAS HAS BEEN USED WITH NO FURTHER ISSUES REPORTED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157536 COOK SPECTRUM TURBO-JECT LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 00827002239166

    Patients

    Seq Age Sex Outcome Treatment
    1