BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC

    MDR report key: 5833069 · Received July 29, 2016

    Report

    Report Number
    1820334-2016-00716
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    July 4, 2016
    Report Date
    August 9, 2017
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002237155
    PMA / PMN Number
    K072625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL DATA, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE SUPPLIED PEEL-AWAY SHEATH INTRODUCER FROM THE TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC HAVING A PRODUCT LABEL LOT NUMBER CONSISTING OF 6958927 WAS RETURNED IN AN OPENED, USED AND DAMAGED CONDITION. THE HANDLES AND THE SPLIT PEEL AWAY SHEATH WERE RETURNED. THE HANDLE WAS BROKEN IN HALF. VISUAL EXAMINATION OF THE HANDLE REVEALED THAT THERE WAS INCOMPLETE FIN FILL WHERE THE HOLE PUNCHES ARE LOCATED. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING-RELATED. MEASURES HAVE BEEN CONDUCTED TO ADDRESS THIS FAILURE MODE. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PLACING THE PICC LINE AND AS THE PEEL AWAY SHEATH WAS BEING PULLED TO BE PEELED AWAY, ONE OF THE HANDLES ON THE SHEATH SNAPPED OFF, LEAVING THE SHEATH STILL ATTACHED TO THE PICC LINE. THE PHYSICIAN MANAGED TO RETRIEVE THE SHEATH FROM THE PICC LINE WITHOUT THE SHEATH HANDLE AND THE LINE WAS SUCCESSFULLY PLACED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PLACING THE PICC LINE AND AS THE PEEL AWAY SHEATH WAS BEING PULLED TO BE PEELED AWAY, ONE OF THE HANDLES ON THE SHEATH SNAPPED OFF, LEAVING THE SHEATH STILL ATTACHED TO THE PICC LINE. THE PHYSICIAN MANAGED TO RETRIEVE THE SHEATH FROM THE PICC LINE WITHOUT THE SHEATH HANDLE AND THE LINE WAS SUCCESSFULLY PLACED. 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
    486491 TURBO-JECT® DOUBLE LUMEN BEDSIDE POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 00827002237155

    Patients

    Seq Age Sex Outcome Treatment
    1