BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISTIK 3 COMFORT

    MDR report key: 7945160 · Received October 8, 2018

    Report

    Report Number
    8021764-2018-00004
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    August 9, 2018
    Report Date
    February 19, 2019
    Manufacturer
    OWEN MUMFORD LIMITED
    Product Code
    FMK
    UDI-DI
    00384701042034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THIS LOT NUMBER OF THE UNISTIK 3 DEVICE HAD NOT BEEN DISTRIBUTED IN THE US, THE SAME MODEL HAS BEEN IN DISTRIBUTION AND THEREFORE THE EVENT WAS REPORTED. AN INVESTIGATION WAS OPENED ON 25 SEP 2018 TO COVER SEVERAL COMPLAINTS OVER A 2 MONTH PERIOD STATING THAT UNISTIK 3 COMFORT DEVICE NEEDLES WERE NOT RETRACTING AFTER USE. FULL REPORT ATTACHED (INV-18-00064 REV 01). - ATTACHMENT: [INV-18-00064 REV. 01.PDF].

    Additional Manufacturer Narrative · 1

    THIS LOT NUMBER WAS NOT DISTRIBUTED IN THE US, HOWEVER, THE SAME MODEL, AT 1042 UNISTIK 3 COMFORT IS DISTRIBUTED IN THE US.

    Description of Event or Problem · 1

    OWEN MUMFORD LIMITED WAS NOTIFIED OF EVENT ON 08 SEP 2018 (B)(6). A NURSE TOOK A BLOOD SAMPLE OF A BABY IN NEONATOLOGY SERVICE WITH THE UNISTIK 3 COMFORT DEVICE. WHEN SHE WAS REMOVING HER GLOVES SHE WAS INJURED WITH THE DEVICE. SHE HAS A MARK ON THE THUMB WITH EXTENSIVE BLEEDING, AS THE NEEDLE DID NOT RETRACT ENTIRELY INTO THE BODY OF THE DEVICE. SHE HAS NOT RECEIVED ANY FOLLOW-UP AND TREATMENT IN TERMS OF SEROLOGY POST NSI, AS THE PATIENT WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785472 UNISTIK 3 COMFORT LANCET FMK OWEN MUMFORD LIMITED AT 1042 028163 00384701042034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other