BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F MINI DIGNITY CT PORT

    MDR report key: 3862743 · Received May 28, 2014

    Report

    Report Number
    2518902-2014-00036
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. A PHOTOGRAPH OF THE DEVICE WAS PROVIDED. THE PHOTOGRAPH SHOWS WHAT APPEARS TO BE A HOLE IN THE PORT BASE ON THE EDGE OF THE "C" THAT IS PRINTED ON THE BASE. IN ADDITION, THERE ARE TWO MARKS ON THE BASE THAT APPEAR TO BE BUMPS AND DO NOT FULLY PENETRATE THE BASE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. A REVIEW OF THE ENGINEERING FILES NOTED THAT IF REQUIRED 14, 17 LBS OF FORCE TO PUNCTURE THE PORT BASE WITH A 19GA NEEDLE. THE 22GA NEEDLES BENT PRIOR TO PUNCTURING THE BASES. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT WITHOUT AN EVALUATION OF THE DEVICE INVOLVED,

    Description of Event or Problem · 1

    ACCESSED BY EMERGENCY DEPARTMENT MIDNIGHT SUNDAY (B)(6) 2014 TO BE ADMITTED. GOT ANTIBIOTICS; THEN THE PORT DIDN'T GIVE BLOOD RETURN. MEDICAL DOCTOR TOOK X-RAY VS. RN REQUESTING CONTRAST STUDY; X-RAY SHOWED INTACT PORT, RN RE-ACCESSED PORT AND SAME THING OCCURRED. MOM SAID NO MORE ACCESSING; PUT IV INTO PATIENT AND PORT WAS NOT USED UNTIL FLUOR STUDY NEXT DAY. PORT WAS REMOVED BY SURGEON AND A NEW PORT WAS PLACED; CHILD OK AFTER SURGERY AND DISCHARGED HOME ON TUESDAY (B)(6) 2014. A HOLE IN THE BASE OF THE PORT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314632 5F MINI DIGNITY CT PORT IMPLANATABLE PORT LJT MEDCOMP MRCT150841MP MBKV850

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention BARD MINI-LOC HUBER NEEDLE-22G 3/4 INCH