BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPT

    MDR report key: 16205630 · Received January 19, 2023

    Report

    Report Number
    3013666218-2023-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 19, 2023
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    DWM
    UDI-DI
    00404694317514
    PMA / PMN Number
    K093307
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND. THERE IS NO NON-CONFORMANCE RECORD ASSOCIATED WITH LOT# 2206-015 THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. COMPLAINT LOG RECORDED FOR YEAR 2022: 1 COMPLAINT RECORDED FOR REF:(B)(4) WITH A SIMILAR ISSUE. THE ASEPT DRAINAGE CATHETER WOULD NOT THREAD THROUGH THE TEAR AWAY SHEATH AFTER MULTIPLE ATTEMPTS. TOTAL SALES OF ASEPT PLEURAL/PERITONEAL DRAINAGE SYSTEM = (B)(4) UNITS OCCURRENCE RATE = .007%. REVIEW OF RISK ANALYSIS: RISK IS IDENTIFIED WITHIN THE RISK ANALYSIS; POTENTIAL OCCURRENCE'S RATE OF 0.01 %. RETAINED SAMPLE EVALUATION: THE RETAIN SAMPLE WAS FULLY INSPECTED. THE TEARAWAY INTRODUCER WAS NOT KINKED, HAD NO ISSUES PULLING IN/OUT OF SHEATH, AND THE DISTAL END HAS NO NOTICEABLE DAMAGE. CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE RETAIN SAMPLE FROM THE SAME LOT WAS VISUALLY INSPECTED AND NO DEVIATION WAS FOUND. GIVEN THAT THE TEARAWAY INTRODUCER BECAME KINKED DURING THE PROCEDURE, IT IS POSSIBLE THAT RESISTANCE WAS ENCOUNTERED AGAINST THE ANATOMY DURING ADVANCEMENT; HOWEVER, THIS COULD NOT BE CONFIRMED. PLEASE NOTE THAT THE IFU INDICATES AVOIDING EXCESSIVE MANIPULATION OF THE SHEATH WHEN THE DILATOR IS NOT INSERTED AND AVOID KINKING OF THE SHEATH AS IT MAY MAKE IT DIFFICULT TO PASS THE CATHETER THROUGH. THE RISK IS IDENTIFIED WITHIN THE RISK ANALYSIS AND THE OCCURRENCE RATE IS BELOW THE ACCEPTABLE FREQUENCY OF THE RISK ANALYSIS. THE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. FOR FUTURE COMPLAINTS, THE RETURN OF THE COMPLAINT PRODUCT IS ESSENTIAL FOR A COMPLETE INVESTIGATION. PFM MEDICAL, INC. WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    PEEL-AWAY INTRODUCER KINKED DURING PROCEDURE, WHICH RESULTED IN DIFFICULTY ADVANCING THE ASEPT CATHETER. INTRODUCER REMOVED AND INSPECTED SHOWING THE DISTAL END WAS KINKED. PULLED A NEW PEEL-AWAY INTRODUCER OUT OF A 2ND ASEPT KIT AND RE ADVANCED THE CATHETER THROUGH THE 2ND PEEL-AWAY INTRODUCER. THE PATIENT WENT IN FOR A CT SCAN BECAUSE THE CATH SEEMED TO BE PLACED LOW IN THE THORACIC CAVITY. ADMITTED TO ICU FOR MONITORING-BC THE CT SCAN SHOWED THE CATHETER MALPOSITIONED IN THE RIGHT HAPATIC VEIN/IVC. TRAUMA MDS THEN REMOVED THE ASEPT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034010 ASEPT PLEURAL DRAINAGE CATHETER DWM PFM MEDICAL, INC. 622289 2206-015 00404694317514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention