BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO 45MM NEEDLE (EA)

    MDR report key: 6969648 · Received October 23, 2017

    Report

    Report Number
    3011137372-2017-00315
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    June 29, 2017
    Report Date
    October 2, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DHR FILE NOT AVAILABLE FOR REVIEW IN THE US. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "USE OF THE EZ-STABILIZER IS STRONGLY RECOMMENDED FOR ALL EZ-IO INSERTIONS". THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION PURPOSES. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. THIS COMPLAINT INVOLVES A PATIENT COMPLICATION, NOT A PRODUCT MALFUNCTION. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    PER ARTICLE RECEIVED PUBLISHED BY: BROMBERG R, DAVE K, MANKODI D, ET AL. BMJ CASE REP 2017 (EPUB AHEAD OF PRINT). DOI:10.1136/BCR-2017- 220069. THIS CASE REPORT DESCRIBES A COMPLICATION OF A LACERATION THAT OCCURRED IN AN (B)(6) MORBIDLY OBESE FEMALE THAT PRESENTED IN SEPTIC SHOCK AND RECEIVED A PROXIMAL TIBIAL IO PLACEMENT USING THE EZIO DEVICE. A 45 MM NEEDLE SET WAS USED FOR THE INITIAL INSERTION, WHICH WAS COMPLETED WITHOUT ANY INITIAL PROBLEMS; NO STABILIZER WAS PLACED. THE PATIENT HAD FLUID RESUSCITATION VIA THE IO SITE WITH RAPIDLY IMPROVED HEMODYNAMICS. DURING TRANSPORT SHE DEVELOPED A 7 CM LACERATION ACROSS THE IO INSERTION SITE. THE CATHETER WAS REMOVED AND LACERATION SUTURED. AUTHORS OPINED THAT THE LACK OF USE OF THE EZ-STABILIZER DRESSING, THE AMOUNT OF SOFT TISSUE AND THIN SKIN AND TRACTION FORCES ON THE IO SITE APPLIED DURING TRANSPORT CONTRIBUTED TO THIS COMPLICATION.

    Description of Event or Problem · 1

    PER ARTICLE RECEIVED PUBLISHED BY: BROMBERG R, DAVE K, MANKODI D, ET AL. BMJ CASE REP 2017 (EPUB AHEAD OF PRINT). DOI:10.1136/BCR-2017- 220069 THIS CASE REPORT DESCRIBES A COMPLICATION OF A LACERATION THAT OCCURRED IN AN (B)(6)MORBIDLY OBESE FEMALE THAT PRESENTED IN SEPTIC SHOCK AND RECEIVED A PROXIMAL TIBIAL IO PLACEMENT USING THE EZIO DEVICE. A 45 MM NEEDLE SET WAS USED FOR THE INITIAL INSERTION, WHICH WAS COMPLETED WITHOUT ANY INITIAL PROBLEMS; NO STABILIZER WAS PLACED. THE PATIENT HAD FLUID RESUSCITATION VIA THE IO SITE WITH RAPIDLY IMPROVED HEMODYNAMICS. DURING TRANSPORT SHE DEVELOPED A 7 CM LACERATION ACROSS THE IO INSERTION SITE. THE CATHETER WAS REMOVED AND LACERATION SUTURED. AUTHORS OPINED THAT THE LACK OF USE OF THE EZ-STABILIZER DRESSING, THE AMOUNT OF SOFT TISSUE AND THIN SKIN AND TRACTION FORCES ON THE IO SITE APPLIED DURING TRANSPORT CONTRIBUTED TO THIS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748059 EZ-IO 45MM NEEDLE (EA) NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention