BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC

    MDR report key: 6683458 · Received July 1, 2017

    Report

    Report Number
    1820334-2017-01613
    Event Type
    Injury
    Date Received
    July 1, 2017
    Date of Event
    May 30, 2017
    Report Date
    October 19, 2017
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002056763
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LINE EXPERIENCED A PARTIAL SEPARATION AT THE CONNECTION OF THE TUBING TO THE END OF THE HUB. THE LINE WAS BEING USED FOR TOTAL PARENTERAL NUTRITION (TPN). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. ADDITIONAL COMMON NAME: FOZ ¿ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS. ADDITIONAL PRODUCT CODE: FOZ. 510(K): K100974. INVESTIGATION - EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, QUALITY CONTROL DATA, COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND VISUAL INSPECTION / FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED IN USED CONDITION. THE EXTENSION TUBE WAS NOTED TO BE SPLIT RIGHT UNDERNEATH THE DISTAL PART OF THE ORANGE HUB. A LEAK TEST SHOWED LEAKAGE AT THE SPLIT. THE OUTER DIAMETER OF THE EXTENSION TUBE WAS WITHIN SPECIFICATION. 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 WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS FAILURE MODE ON THIS LOT NUMBER. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT, AND RESULTS OF THE INVESTIGATION; A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEASURES HAVE BEEN CONDUCTED TO ADDRESS THIS FAILURE MODE. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC ON (B)(6) 2017. THE PICC LINE BROKE ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT CATHETER EXPLANT AND REPLACEMENT WITH A BROVIAC CATHETER UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463944 SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 00827002056763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention