BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC

    MDR report key: 8116416 · Received November 29, 2018

    Report

    Report Number
    1820334-2018-03414
    Event Type
    Injury
    Date Received
    November 29, 2018
    Report Date
    January 17, 2019
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002345119
    PMA / PMN Number
    K132334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION HAS PREVIOUSLY BEEN REPORTED, IS UNKNOWN OR IS UNAVAILABLE. DEVICE EVALUATION: ONE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL EXAM NOTES CLEAR TUBING IS PARTIALLY SEPARATED AT THE PURPLE HUB. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. INVESTIGATION: A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: INSTRUCTIONS FOR USE, QUALITY CONTROL SPECIFICATIONS, DOCUMENTATION, AND COMPLAINT HISTORY. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. REVIEW OF DEVICE HISTORY RECORD DID NOT OBSERVE ANY NONCONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A SEARCH OF THE MANUFACTURER'S COMPLAINT DATABASE IDENTIFIED THIS COMPLAINT TO BE THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 9101421. RISK ASSESSMENT DETERMINED THAT RISK CONTROLS ARE IN PLACE TO MITIGATE THIS FAILURE MODE. THE APPROPRIATE PERSONNEL WERE NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE DEVICE EVALUATION AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WAS DETERMINED AS CAUSE TRACED TO DEVICE DESIGN (DESIGN INADEQUATE FOR PURPOSE). APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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)(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

    IT WAS REPORTED THE PURPLE HUB ON A TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC WAS FOUND CRACKED. THIS LUMEN WAS BEING USED TO INFUSE TOTAL PARENTERAL NUTRITION(TPN.) THE DEVICE WAS REMOVED AND REPLACED DURING AN ADDITIONAL PROCEDURE. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN PLACE AND WHEN IT WAS REMOVED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH REGARDS TO THE DEVICE, EVENT, AND PATIENT DETAILS BUT HAVE NOT BEEN PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954680 TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC NA 9101421 00827002345119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention