BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SETS

    MDR report key: 13839804 · Received March 21, 2022

    Report

    Report Number
    3012307300-2022-04967
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 21, 2022
    Report Date
    June 2, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586020346
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. TWO (2) PICTURES WERE ATTACHED IN THE COMPLAINT REPORT: THESE PICTURES WERE VISUALLY ANALYZED, THE PHOTOS 1 AND 2 COULD BE OBSERVED MARKS THE TUBE (WITH THESE PHOTOS THE FAILURE MODE REPORTED IS CONFIRMED). VISUAL INSPECTION: EIGHTEEN (18) PHYSICAL SAMPLES DECONTAMINATED WERE RETURNED FOR EVALUATION; THE SAMPLES WERE ANALYZED. THE SAMPLES WERE OBSERVED WITH MARKS IN THE TUBE (CLAMP MARK). THEREFORE, THE COMPLAINT IS CONFIRMED. IT WAS TRIED TO REPLICATE THE FAILURE MODE FOLLOWING THE STEP BELOW: A SAMPLE OF SET, EXTENSION WAS ACTIVATED THE CLAMP. RESULT: WHEN THE CLAMP WAS DEACTIVATED, THE TUBE WAS OBSERVED WITH A MARK. THE SAME SAMPLE WAS TESTED USING A SYRINGE WITH COLORED WATER TO DETECT ANY LEAK, OCCLUSION, OR ANY PROBLEM WITH THE FUNCTIONALITY OF THE PRODUCT. RESULT: NO PROBLEM WAS FOUND WITH THE SAMPLE. THE MARK OF THE RETURNED SAMPLES WERE COMPARED WITH THE SAMPLE OF SET, EXTENSION (ACTIVATED THE CLAMP), THE MARK IS SIMILAR. ACCORDING TO THE TESTS CARRIED OUT, WE CAN SEE THAT THE MARK ORIGINATES WHEN THE CLAMP IS ACTIVATED. BASED THE ANALYSIS THE ROOT CAUSE IS THE CLAMP WAS CLOSED OR MANIPULATED DURING MANUFACTURING PROCESS AND THIS ORIGIN THE PINCH MARKS FOUND IN THE TUBE AND PRODUCTION PERSONNEL DID NOT DETECT THE DAMAGE OF THE UNIT. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. SUMMARY OF DHR REVIEW: THERE WERE NO DEVIATIONS DOCUMENTED IN THE DEVICE HISTORY RECORD, RELATED TO THE PROCESS AND COMPONENTS THAT CONFORMS THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2022-04967. THE REPORT WAS SUBMITTED IN ERROR., CORRECTED DATA: CORRECTED INFORMATION PROVIDED IN H10.

    Description of Event or Problem · 0

    1/15 REFERENCE (B)(4) FOR ALL ATTACHMENTS AND RELATED COMPLAINTS). PER COMPLAINT FORM IT WAS REPORTED EXTENSION LINES ARE KINKED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545241 CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7052-24 4152708 10610586020346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown