BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED AMBULATORY 60 INCH TUBE SET WITH PRESSURE CELL AND MALE LUER LOCK

    MDR report key: 6012468 · Received October 7, 2016

    Report

    Report Number
    1723533-2016-00174
    Event Type
    Injury
    Date Received
    October 7, 2016
    Report Date
    September 8, 2016
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K873961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER FOLLOW UP CONVERSATIONS WITH THE PATIENT'S CLINIC, THE PATIENT RECEIVED A TEMPORARY CATHETER TO COMPLETE HER TREATMENT AND THE PATIENT WAS FINE. WALKMED INFUSION WAS UNABLE TO CONFIRM WHETHER THE PATIENT RECEIVED MEDICAL INTERVENTION AT THE EMERGENCY ROOM. A FAX WAS SENT TO THE EMERGENCY ROOM TO REQUEST THIS INFORMATION. IF AND WHEN THIS INFORMATION IS RECEIVED, WALKMED INFUSION WILL FILE A FOLLOW UP REPORT. THE DEVICE IN QUESTION WAS DISCARDED AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED. DEVICE DISCARDED BY CLINIC.

    Additional Manufacturer Narrative · 1

    WALKMED INFUSION RECEIVED THE PHYSICIAN NOTES FROM (B)(6) HEALTH'S EMERGENCY DEPARTMENT. THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT ON (B)(6) 2016 AT 15:35. THE PATIENT WAS EXAMINED AND WAS INSTRUCTED TO RETURN THE FOLLOWING DAY ((B)(6) 2016) TO HAVE HER PORT REMOVED. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL MEDICAL INTERVENTION. THE PATIENT'S CLINIC CONFIRMED THE PATIENT RECEIVED A TEMPORARY CATHETER TO RECEIVE HER FINAL TREATMENT ON (B)(6) 2016. THE PATIENT WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    WHILE CONNECTED TO WALKMED INFUSION'S PS-360 AMBULATORY ADMINSTRATION SET, A PATIENT'S INFUSION PORT SITE WAS INFECTED. ADDITIONALLY, THE CLINICIAN OBSERVED THE LEFT SIDE OF THE PATIENT'S CHEST AND THE PATIENT'S NECK TO BE SWOLLEN. THE PATIENT WAS SENT TO AN EMERGENCY ROOM FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661957 WALKMED AMBULATORY 60 INCH TUBE SET WITH PRESSURE CELL AND MALE LUER LOCK INTRAVASCULAR ADMINSTRATION SET FPA WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization