BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SETS

    MDR report key: 14103138 · Received April 13, 2022

    Report

    Report Number
    3012307300-2022-06310
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 28, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586024177
    PMA / PMN Number
    K000942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) , AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. ONE SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING, IN USED CONDITION, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL INSPECTION WAS PERFORMED AT 12 TO 16 INCHES UNDER NORMAL CONDITIONS OF ILLUMINATION. VISUAL INSPECTION SHOWED THERE WAS NO DAMAGE, KINKS, VOIDS OR BAD BONDING. DURING THE OCCLUSION TEST AN OCCLUSION WAS OBSERVED IN THE TUBE WITH THE LUER. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO EXCESS OF SOLVENT IN ONE OF THE BONDING UNIONS (LUER - TUBING UNION / TUBING FILTER UNION) BY MANUFACTURING CAUSED THE OCCLUDED TUBE. AWARENESS NOTIFICATION WAS GENERATED TO EXPLAIN THE IMPORTANCE OF FOLLOWING UP CORRECTLY THE BONDING PROCESS DOCUMENTED IN THE STANDARD OPERATING PROCEDURE. E4 WAS UNKNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THE CASSETTE, A OCCLUSION MESSAGES OCCURRED THOUGH ALL THE LINE HAS BEEN CLEARED FROM OBSTRUCTIONS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787681 CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7092-24 4135476 10610586024177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown