BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL BOLUS NEEDLE HAI STRAIGHT LENGTH 1 3/8" (3.5CM)

    MDR report key: 25178981 · Received May 14, 2026

    Report

    Report Number
    3015537318-2026-00050
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 13, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    PTI
    PMA / PMN Number
    K211121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INTERA ONCOLOGY COMMUNICATED WITH THE CLINIC TO OBTAIN ADDITIONAL INFORMATION. THE CLINIC HAS NOT RELEASED ANY INFORMATION DUE TO HIPAA CONCERNS. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS INCONCLUSIVE.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED THAT ON (B)(6) 2026, AN INTERVENTIONAL RADIOLOGY NURSE MENTIONED THAT THE CLAMP ON THE SPECIAL BOLUS NEEDLE (SBN) THAT WAS USED DURING A HAPS SCAN DIDN'T CLAMP THE TUBE AND CAUSED BLOOD TO FLOW INTO THE SBN TUBE. THE NURSE STATED THAT THE CLAMP WORKED, BUT THE TUBE WAS STILL COMPLETELY OPEN, AND IT WAS JUST GOING AROUND THE CLAMP. AFTER FLUSHING THE SBN WITH 10ML OF INJECTABLE SALINE HE WAS SUCCESSFUL AT CLAMPING THE SBN WITHOUT GETTING ANY BACKFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192760 SPECIAL BOLUS NEEDLE HAI STRAIGHT LENGTH 1 3/8" (3.5CM) INTERA NON-CORING (HUBER) SPECIAL BOLUS NEEDLES PTI INTERA ONCOLOGY, INC AP-04013-5 25L011CT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown