BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC

    MDR report key: 5103454 · Received September 25, 2015

    Report

    Report Number
    1820334-2015-00586
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002239050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). INVESTIGATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL (QC) AND TRENDS WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. A SEARCH WAS CONDUCTED REGARDING LOT 5932920. THERE ARE TWO REPORTED COMPLAINTS ON THIS LOT, BOTH REPORTED BY THE SAME CUSTOMER. DEVICES ARE STATISTICALLY TESTED TO ENSURE ALL BONDS & SHAFT TUBING WITHSTAND A MINIMUM PULL TEST. SMALL LUMEN AND BOTH PURPLE AND WHITE LUMENS ARE PRESSURE TESTED AND MUST WITHSTAND 150PSI. FINAL QC INSPECTS THE DEVICE TO ENSURE LUMENS, EXTENSION TUBES, MANIFOLD, AND SHAFT HAVE CLEAR COMMUNICATION, ARE FREE OF OBSTRUCTIONS, AND ARE SECURELY MOLDED TO MANIFOLD WITHOUT VOIDS OR FLAWS. THE DEVICE IS PACKAGED WITH AN IFU WHICH GIVES DEVICE DESCRIPTION, INTENDED USE, WARNINGS, PRECAUTIONS, RECOMMENDATIONS FOR PLACEMENT AND MAINTENANCE AND INSTRUCTIONS FOR PROPER USE OF THE DEVICE. WITHOUT EXAMINATION OF THE RETURNED DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. HOWEVER, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CT RATED PICC LINE WAS INSERTED IN THE PATIENT. THE PICC WAS NOTED TO SPLIT ON (B)(6) 2015 WHERE IT JOINS AT BASE OF HUB. IT WAS REMOVED AND A NEW PICC WAS RE-INSERTED. THERAPY HAD TO BE STOPPED AND THE PATIENT REQUIRED ANOTHER PICC PLACED. THE PATIENT ALSO HAD A 'SIGNIFICANT THROMBUS' ASSOCIATED WITH THIS PICC. ACCORDING TO THE INITIAL REPORTER, HOSPITAL STAY WAS EXTENDED. THE PATIENT INSISTED THE PICC BE REINSERTED BY THE INTERVENTIONAL RADIOLOGY DEPARTMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CT RATED PICC LINE WAS INSERTED IN THE PATIENT. THE PICC WAS NOTED TO SPLIT ON (B)(6) 2015 WHERE IT JOINS AT BASE OF HUB. IT WAS REMOVED AND A NEW PICC WAS RE-INSERTED. THERAPY HAD TO BE STOPPED AND THE PATIENT REQUIRED ANOTHER PICC PLACED. THE PATIENT ALSO HAD A 'SIGNIFICANT THROMBUS' ASSOCIATED WITH THIS PICC. ACCORDING TO THE INITIAL REPORTER, HOSPITAL STAY WAS EXTENDED. THE PATIENT INSISTED THE PICC BE REINSERTED BY THE (B)(6) RADIOLOGY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634061 TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 5932920 00827002239050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization