BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL BLOOD PROCESSING DEVICE

    MDR report key: 12640353 · Received October 15, 2021

    Report

    Report Number
    3012307300-2021-10003
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 1, 2021
    Report Date
    May 4, 2023
    Manufacturer
    NULL
    Product Code
    PZV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION ADDED TO H6 AND H10. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. TWO SAMPLES WERE RETURNED AND VISUALLY INSPECTED. THE FIRST ONE APPEARS UNDAMAGED. NO ANOMALIES FOUND. THE SECOND ONE SHOWED A STRETCHED TUBE, DAMAGED AT 14.5 MM DISTANCE FROM THE HUB. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE A POTENTIAL IMPROPER USE OF THE DEVICE AS POTENTIAL ROOT CAUSE OF THE COMPLAINT. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, THE FORE END OF THE CATHETER WAS PARTIALLY MISSING AND WAS ALSO DAMAGED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541556 PERIPHERAL BLOOD PROCESSING DEVICE PZV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown