BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    MDR report key: 6816235 · Received August 24, 2017

    Report

    Report Number
    1820334-2017-02535
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 10, 2017
    Report Date
    December 13, 2017
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002037885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PRODUCT CODE: LJS; (B)(4); PMA/510(K): K111244. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: REPORT SOURCE, DEVICE AVAILABLE FOR EVALUATION: DEVICE WAS RECEIVED ON 24DEC2017; HOWEVER, IT WAS AFTER THE INITIAL REPORT WAS SUBMITTED. (B)(4). THE WIRE GUIDE WAS OBSERVED TO BE BENT/ KINKED UPON INSPECTION FOLLOWING RECEIPT OF THE DEVICE. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE OPENED TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC WAS RETURNED. THE WIRE IS THE ONLY COMPONENT THAT APPEARS TO HAVE BEEN USED AND IS IN THE PROTECTIVE HOLDER WITH THE TAG ATTACHED. MEASUREMENTS OF THE WIRE GUIDE WERE PERFORMED. EVALUATION OF THE RETURNED WIRE CONFIRMED DIMENSIONS TO BE WITHIN SPECIFICATION, ALTHOUGH IT WAS NOTED THAT THE DISTAL TIP WAS BENT/ KINKED, RENDERING IT NON-FUNCTIONAL. THE WIRE COIL APPEARS TO HAVE BENT/ KINKED WITHOUT ANY SOLDER FAILURE. NO CORE MANDREL/ WIRE IS PROTRUDING, AND NOTHING CAN BE VIEWED BETWEEN THE COIL REVOLUTIONS. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, AS THE WIRE WAS IN ACCEPTABLE CONDITION PRIOR TO USAGE, THIS EVENT IS RELATED TO PROCEDURE/ TECHNIQUE, HANDLING, OR PATIENT ANATOMY. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT WHEN THE OPERATOR OF THE TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC WAS ATTEMPTING TO FIND AND ACCESS A VEIN, THE TIP OF THE WIRE GUIDE BROKE AND THE WIRE GUIDE COULD NO LONGER BE USED. ANOTHER WIRE GUIDE WAS USED TO PROCEED WITH THE PROCEDURE. THE CUSTOMER REPORTED THAT THIS INCIDENT HAD NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599127 TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC LJS COOK INC N/A 00827002037885

    Patients

    Seq Age Sex Outcome Treatment
    1