BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    MDR report key: 7644964 · Received June 28, 2018

    Report

    Report Number
    1820334-2018-01828
    Event Type
    Injury
    Date Received
    June 28, 2018
    Report Date
    August 14, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002037885
    PMA / PMN Number
    K111244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), TRENDS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. NO ISSUES WERE FOUND RELATED TO THE REPORTED COMPLAINT. 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. THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. PHOTOGRAPHS WERE NOT PROVIDED. IF THE DEVICE IS RETURNED FOR INVESTIGATION THE RECORD WILL BE UPDATED AT THAT TIME. WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO DETERMINE IF THIS IS A MANUFACTURING ISSUE. BASED ON THE ARTICLE AND CURRENT INFORMATION, THE MOST PROBABLE CAUSES OF THIS EVENT ARE MEDICAL PROCEDURE AND DISEASE PROGRESSION RELATED. 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. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. 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

    NO ADDITIONAL INFORMATION HAS BEEN REPORTED SINCE THE SUBMISSION OF THE INITIAL REPORT ON 06/28/2018.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: SAID TO HAVE OCCURRED IN 2015. (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

    FERNANDO R, LEE YJ, KHAN N, KAZMI F. DELAYED MIGRATION OF A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TO THE AZYGOS VEIN WITH SUBSEQUENT PERFORATION. BJR CASE REP 2016; 2: 20150315. THE BRITISH INSTITUTE OF RADIOLOGY PUBLISHED A CASE STUDY INVOLVING A TURBO-JECT STANDARD POWER INJECTABLE PICC LINE DURING A DIAGNOSTIC LAPAROSCOPY. A CASE OF DELAYED MIGRATION OF A PICC INSERTED FOR TPN FROM THE SUPERIOR VENA CAVA INTO THE AZYGOS VEIN THAT WAS NOT INITIALLY RECOGNIZED ON CHEST RADIOGRAPHS OR CT SCAN. THIS SUBSEQUENTLY LED TO AZYGOS PERFORATION AND EXTRAVASATION OF THE TPN SOLUTION INTO THE MEDIASTINAL, PLEURAL AND PERICARDIAL SPACES. SEVERAL ANATOMICAL AND PROCEDURAL FACTORS PREDISPOSE TO PICC MIGRATION. IN THIS PATIENT, THE RISK OF PICC MIGRATION WAS INCREASED BY LEFT SIDED INSERTION AND VARIANT AZYGOS ANATOMY. IF A CURVE IN THE DISTAL TIP OF A PICC IS SEEN ON A FRONTAL CHEST RADIOGRAPH, AZYGOS MALPOSITION SHOULD BE SUSPECTED AND CONFIRMED WITH A LATERAL RADIOGRAPH, CT SCAN OR CATHETER INJECTION. THIS IS BECAUSE AZYGOS MALPOSITION INCREASES THE RISK OF VENOUS PERFORATION AND NEEDS TO BE CORRECTED. THE PATIENT REMAINED CLINICALLY STABLE AND MADE A GOOD RECOVERY. SHE WAS DISCHARGED HOME A WEEK AFTER REMOVAL OF THE PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488378 TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC G03788 6243806 00827002037885

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention