BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 8655679 · Received May 30, 2019

    Report

    Report Number
    1820334-2019-01315
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 11, 2019
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002345195
    PMA / PMN Number
    K132334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. A1 - PATIENT IDENTIFIER: (B)(6). INVESTIGATION - EVALUATION A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL, SPECIFICATIONS AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL EXAMINATION OF THE DEVICE NOT CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY AND FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE RISK SPECIFICATION FOR THIS PRODUCT INCLUDES THE LOSS OF USE FAILURE MODE AND IDENTIFIES THE RISK CONTROLS THAT ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO RELEVANT NONCONFORMANCES IN LOT 9033234 THAT COULD HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE. IT SHOULD BE NOTED THAT THERE WERE TWO ADDITIONAL COMPLAINTS REPORTED FOR THIS LOT FROM THE SAME CUSTOMER, IN WHICH ONE WAS RELATED TO THIS FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INTENDED USE THE MAXIMUM PRESSURE LIMIT SETTING FOR POWER INJECTORS USED WITH THE TURBO-JECT PICC MAY NOT EXCEED 325 PSI AND THE FLOW RATE MAY NOT EXCEED THE MAXIMUM FLOW RATE INDICATED. WARNINGS THE SAFE AND EFFECTIVE USE OF TURBO-JECT PICC LINES WITH POWER INJECTOR PRESSURES SET ABOVE 325 PSI HAS NOT BEEN ESTABLISHED. DO NOT POWER INJECT IF MAXIMUM INJECTION RATE CANNOT BE VERIFIED TO MEET LIMIT PRINTED ON CATHETER HUB OR EXTENSION TUBE. TO SAFELY USE TURBO-JECT PICC LINES WITH A POWER INJECTOR, THE TECHNICIAN/HEALTH CARE PROFESSIONAL MUST VERIFY: THE CATHETER LUMEN HAS ¿CT" ON THE HUB TO INDICATE THE LUMEN IS POWER INJECTABLE.¿ PRIOR TO USE THAT THE MAXIMUM PRESSURE LIMIT IS SET AT OR BELOW 325 PSI AND THAT THE MAXIMUM LOW RATE IS AT OR BELOW THAT WHICH IS LISTED ON THE CATHETER. PRECAUTIONS IF LUMEN FLOW IS IMPEDED, DO NOT FORCE INJECTION OR WITHDRAWAL OF FLUIDS. NOTIFY ATTENDING PHYSICIAN IMMEDIATELY. HOW SUPPLIED SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOK PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. IT IS FEASIBLE TO SUGGEST THAT THE TEAR COULD HAVE OCCURRED BECAUSE OF AN IMPEDIMENT DURING THE PROCEDURE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: SENIOR ANESTHESIA TECH. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR TREATMENT AT AN OUTPATIENT CLINIC. THE PATIENT WAS GIVEN 100ML INFUSION, FOLLOWED BY A 30ML FLUSH. WHEN THE FLUSH WAS STARTED, FLUID BEGAN TO LEAK OUT THE INSERTION SITE. UPON REMOVAL OF THE PICC LINE, "A SMALL TEAR DOWN THE LINE 5-6CM IN THE LINE UNDER THE SKIN" WAS FOUND. THE PICC LINE WAS INSERTED ON (B)(6) 2019. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448170 TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 9033234 00827002345195

    Patients

    Seq Age Sex Outcome Treatment
    1