BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTICARE

    MDR report key: 3131474 · Received May 10, 2013

    Report

    Report Number
    2135402-2013-00001
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ULTIMED, INC
    Product Code
    FMI
    PMA / PMN Number
    K100812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED 1 PNUG HOUSING WITH 97 EA PEN NEEDLES, LOT # 8130109. REVIEW OF DEVICE HISTORY FILES TO INCLUDE IN - PROCESS TESTING AND FINAL RELEASE PACKET INDICATED NO ISSUES WITH THIS LOT OTHER THAN ONE (1) PEN NEEDLE PULLED OUT WITH A FORCE OF 5.31LBS. THE ISO REQUIREMENT FOR THE AMOUNT OF FORCE TO REMOVE THE CANNULA FROM THE HUB IS EQUAL TO OR GREATER THAN 5 LBS. LOWEST PULL TEST ON IN PROCESS TESTING WAS 5.31 LBS WITH AN AVERAGE OF 10.46 LBS ON THAT SAME TEST SET. THE 7.74 LBS WAS THE MINIMUM ON THE FINAL LOT TESTING, WITH AN AVERAGE OF 7.69 LBS. NO OTHER COMPLAINTS ON THIS LOT. PERFORMED PULL TEST OF 20 EACH RETURNED AND 20 EACH RETAIN SAMPLES. LOWEST PULL ON THE RETURN SAMPLES WAS 9.34 LBS, LOWEST PULL ON THE RETAIN SAMPLES WAS 9.61 LBS. ON (B)(6) 2013: LEFT MESSAGE FOR CUSTOMER ON HER VM. ON (B)(6) 2013: CUSTOMER CALLED BACK SAID THAT SHE DID RECEIVE THE REPLACEMENT NEEDLES AND THEY ARE WORKING MUCH BETTER.

    Description of Event or Problem · 1

    CUSTOMER STATED SHE HAD A NEEDLE BREAK OFF INSIDE OF HER STOMACH. SHE WENT TO THE HOSP AND THEY DID AN ULTRASOUND AND SAW IT IN THERE. LOT# 8130109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209427 ULTICARE 8MM 31G X 5/16" PEN NEEDLE FMI ULTIMED, INC NA 8130109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK