BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 5264072 · Received December 3, 2015

    Report

    Report Number
    1820334-2015-00802
    Event Type
    Injury
    Date Received
    December 3, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    COOK INC
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K132885. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K): K132885. INVESTIGATION: A REVIEW OF COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS (MI) AND QUALITY CONTROL (QC) WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS NOT RETURNED AND THEREFORE A PHYSICAL EVALUATION COULD NOT BE COMPLETED. THERE WERE NO NONCONFORMITIES WITHIN THIS LOT. A COMPLAINT SEARCH HAS SHOWN THAT THIS IS THE ONLY COMPLAINT FOR LOT # 5939412. THE CATHETER IS DRY LEAK TESTED TO CONFIRM ITS FREE OF ANY LEAKS AND/OR COMMUNICATIONS BETWEEN LUMENS AND IN MANIFOLD. THIS TESTING WOULD CONSEQUENTIALLY IDENTIFY POTENTIAL FRACTURES AND/OR CRACKS WITHIN THE HUB AS THE DEVICE IS BUILT TO COMPLETION DURING TESTING. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT UNEXPECTED BENDING OCCURRED ON THE HUB, THUS CAUSING IT TO SNAP; HOWEVER, IT CANNOT BE CONFIRMED DEFINITIVELY AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A PICC LINE, THE PURPLE HUB SNAPPED CLEAN OFF AND THE PATIENT WENT BACK TO THE WARD FOR PLATELET COVER TO REMOVE THE PICC. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A PICC LINE, THE PURPLE HUB SNAPPED CLEAN OFF AND THE PATIENT WENT BACK TO THE WARD FOR PLATELET COVER TO REMOVE THE PICC. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794535 TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1