BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC

    MDR report key: 7337888 · Received March 14, 2018

    Report

    Report Number
    1820334-2018-00707
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Report Date
    June 26, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    PMA / PMN Number
    K132885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B3-- DATE OF EVENT: FROM JUNE 2017-DEC 2017. H10 ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER, "MOST PATIENTS WERE CANCER PATIENTS RECEIVING CHEMOTHERAPY. THE ONLY PRODUCTS AND EQUIPMENT USED DURING THE PROCEDURE WAS AN ULTRASOUND MACHINE AND A PAIR OF MYRINGOTOMY FORCEPS TO EFFECT THE TUNNEL IN THE ANTERIOR CHEST WALL FOR THE PICC." SEE RELATED 1820334-2018-00708. INVESTIGATION - EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, TRENDS AND INSPECTION OF UNUSED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE NOR PICTURES COULD BE OBTAINED. TWO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION (LOT NUMBER 8232992). ONE DEVICE WAS OPENED FOR INVESTIGATION. A BENT TEST WAS PERFORMED BY MANUALLY BENDING THE CATHETER MATERIAL OVER COMPLETELY. THE CATHETER MATERIAL WAS FOUND TO RETURN TO NORMAL STATUS, WITH NO CREASES OR WRINKLES NOTED. THE CUSTOMER¿S DIFFICULTY COULD NOT BE RECREATED IN THE UNOPENED DEVICE. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. IFU STATES: WARNINGS - PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS PLAY AN IMPORTANT ROLE IN TREATMENT OF CRITICALLY ILL PATIENTS. EXTREME CAUTION MUST BE USED IN PLACEMENT AND MONITORING OF CATHETERS. PRECAUTIONS - THIS PRODUCT IS INTENDED FOR USE BY HEALTH CARE PRACTITIONERS TRAINED AND EXPERIENCED IN PROPER POSITIONING OF CATHETERS IN THE CENTRAL VENOUS SYSTEM USING PERCUTANEOUS ENTRY (SELDINGER) TECHNIQUE. STANDARD TECHNIQUES FOR PLACEMENT OF VASCULAR ACCESS SHEATHS, CATHETERS AND WIRE GUIDES SHOULD BE EMPLOYED. HOW SUPPLIED - UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, THE ACTUAL ROOT CAUSE WAS DEEMED TO BE INCONCLUSIVE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ESTIMATED TO HAVE OCCURRED BETWEEN MID 2017 AND (B)(6) 2018. (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 INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE INSERTION PROCEDURE, THE TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC WAS TUNNELED INTO THE PATIENT'S SUBCUTANEOUS TISSUE ALONG THE ANTERIOR CHEST WALL, AND BROUGHT TO THE SURFACE NEAR THE RIGHT INTERNAL JUGULAR VEIN. THE PEEL AWAY SHEATH WAS THEN INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN, AND THE INSERTION OF THE PICC WAS TO FOLLOW. HOWEVER, THE PICC LINE WAS FOUND TO BE KINKING, AND THAT KINKING MEMORY WAS RETAINED. AS A RESULT, THE PICC LINE COULD NOT BE UNKINKED AND LED TO BLOCKAGE. THE PICC LINE WAS WITHDRAWN AND A NEW PICC WAS PLACED. THE PRODUCT PROBLEM REPORTEDLY ONLY OCCURRED WITH THE TUNNELING TECHNIQUE; THERE WERE NO PROBLEMS OR CHALLENGES WITH A PERIPHERAL INSERTION. NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181605 TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1