BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUB-Q PORT PERITON (NO C

    MDR report key: 8800099 · Received July 17, 2019

    Report

    Report Number
    3006260740-2019-01987
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    UDI-DI
    00801741025792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED ALLERGIC REACTION AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE PORT/CATHETER. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE PATIENT ALLERGIES; HOWEVER, THE LACK OF A RETURNED SAMPLE PREVENTED BOTH CONFIRMATION OF THE REPORTED EVENT AND IDENTIFICATION OF A ROOT CAUSE(S). THE INVESTIGATION FOR THE ALLERGIC REACTION IS INCONCLUSIVE. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT PART OF A MODEL 0603006 PORT & CATHETER WAS ALLEGEDLY NOT REMOVED BY PHYSICIAN. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED AN ALLERGIC REACTION TO THE CATHETER. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594015 SUB-Q PORT PERITON (NO C PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS 0603006 RESA0344 00801741025792

    Patients

    Seq Age Sex Outcome Treatment
    1