BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSULFONE POLYUETHANE CATHETER

    MDR report key: 6993887 · Received October 27, 2017

    Report

    Report Number
    6993887
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 6, 2017
    Manufacturer
    SMITHS MEDICAL (DELTEC)
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORIGIN OF REPORT: ON FRIDAY, (B)(6) 2017, I ((B)(4), INVESTIGATOR - OF SAFETY, SECURITY AND EMERGENCY MANAGEMENT) RECEIVED A REPORT FROM (B)(6) (WITNESS / OPERATING ROOM MATERIALS COORDINATOR OF A POSSIBLE DEFECTIVE MEDICAL PRODUCT THAT SURGICAL SERVICES HAVE REMOVED FROM THEIR INVENTORY. DEVICE INFO: THE PORT-A-CATH II SYSTEM PROVIDES AN ADD'L OPTION OF POWER INJECTING CONTRAST MEDIA FOR CERTAIN TYPES OF DIAGNOSTIC IMAGING SCANS. PRELIMINARY INVESTIGATION: ON FRIDAY, (B)(6) 2017, UPON RECEIVING THE REPORT PERTAINING TO A MEDICAL DEVICE DEFECT, I TALKED TO (B)(6) (WITNESS / OPERATING ROOM MATERIALS COORDINATOR) TO ENSURE THAT ALL DEFECTIVE PORT-A-CATH DEVICE SYSTEMS HAVE BEEN REMOVED FROM INVENTORY AND ARE SECURED. ON MONDAY, (B)(6) 2017, AT APPROX 1500-HOURS, (B)(6) (PT SAFETY OFFICER) PUT TOGETHER A TEAM OF HOSPITAL PERSONNEL TO LOOK INTO THIS INCIDENT INVOLVING THE DEFECTIVE DEVICE. THE TEAM NOT ONLY CONSISTED OF (B)(6) AND ME, BUT ALSO (B)(6) (WITNESS/ DIRECTOR OF MATERIALS MGMT), (B)(6) (WITNESS/ OF SURGICAL SERVICES), (B)(6) (WITNESS/MANAGER SURGICAL SERVICES), AND (B)(6) (WITNESS/INTERIM CFO). DIAGNOSIS FOR USE: INJECTING CONTRAST MEDIA FOR DIAGNOSTIC IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764762 POLYSULFONE POLYUETHANE CATHETER PORT-A-CATH II POWER P. A. C. LOW PROFILE LJT SMITHS MEDICAL (DELTEC) 21-4473-24 87X095, 87X100

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention