BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABG MICRO 1ML 25 GAUGE 5/8" SL

    MDR report key: 5620463 · Received April 29, 2016

    Report

    Report Number
    8030673-2016-00164
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    April 12, 2016
    Report Date
    December 14, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBT
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF MDR SUBMISSIONS. CORRECTIONS AND ADDITIONAL INFORMATION HAS BEEN COMPLETED. POTENTIAL FOR NEEDLE STICK INJURY AND EXPOSURE TO BLOOD.

    Additional Manufacturer Narrative · 1

    (B)(4). AWAITING FOR SAMPLE RETURN FROM CUSTOMER. ONCE THE SAMPLE IS RECEIVED AN INVESTIGATION WILL BE PERFORMED ON THIS SAMPLE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE OR WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CUS-52457-EXP- SAMPLES WERE RECEIVED FOR EVALUATION; DURING VISUAL INSPECTION IT WAS OBSERVED THAT THE PART NUMBER 070-2080305 (LOCKING CLASP) WAS MISSING IN ALL OF THE SAMPLES, THEREFORE THE ISSUE REPORTED WAS CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND IT WAS NOTICED THAT THE MISSING COMPONENT WAS NOT ON THE LIST OF ITEMS NEEDED FOR ASSEMBLY. TO CORRECT THIS ISSUE GOING FORWARD, THE LIST FOR ASSEMBLY WAS UPDATED TO INCLUDE THIS COMPONENT. IN ADDITION, A VISUAL AID WAS IMPLEMENTED TO HELP PRODUCTION PERSONNEL WHEN ASSEMBLING THIS PRODUCT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED MISSING THE CLAMP ON THE DEVICE. ALSO STATED, "SHE PULLED THE NEEDLE OUT AND ALMOST HAD A STICK HAZARD. WHEN SHE HELD IT DOWN WITH HER THUMB AND PULLED, THE BLOOD WENT EVERYWHERE" SAMPLE IS AVAILABLE AND WILL BE SENT IN. THERE WAS NO HARM TO EITHER THE TECH OR THE PATIENT, HOWEVER BLOOD DID SPLATTER AND DID CAUSE A SAFETY CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275813 ABG MICRO 1ML 25 GAUGE 5/8" SL KIT, SAMPLING, ARTERIAL BLOOD CBT CAREFUSION, INC 0000884993

    Patients

    Seq Age Sex Outcome Treatment
    1 Other