BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER

    MDR report key: 14778313 · Received June 22, 2022

    Report

    Report Number
    3014312726-2022-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    March 7, 2022
    Report Date
    May 16, 2022
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    JKA
    UDI-DI
    00818392018158
    PMA / PMN Number
    K163073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS NOT TO BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE MANUFACTURING PARTNER CHECKED THE BATCH RECORD OF IMPACTED SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER, REF 110201050003, LOT 05109110 WITH NO ANOMALIES FOUND ON BATCH DOCUMENTATION. NO SAMPLES WERE RECEIVED BY THE CUSTOMER FOR EVALUATION. ARCHIVE SAMPLE EVALUATION: VISUAL CHECK: 60PCS OF ARCHIVE SAMPLES WERE VISUALLY CHECKED WITH NO ANOMALIES FOUND. SIMULATION USE TEST: 10PCS OF ARCHIVE SAMPLES HAVE BEEN SELECTED TO SIMULATE BLOOD COLLECTION WITH 10 TIMES PUNCTURING UNDER 1M STATIC PRESSURE. NO ANOMALIES WERE FOUND IN ALL SAMPLES CHECKED. RISK STATEMENT: THE OVERALL RISK ASSESSMENT, GIVEN THE SEVERITY ASSESSMENT OF S2-MINOR INJURY AND A PROBABILITY ASSESSMENT OF P2-LOW, THE FINAL RISK PRIORITY NUMBER OF 4. RISK LEVEL IS IN GREEN AREA/LOW RISK ACCORDING TO OUR RISK MANAGEMENT PROCEDURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHEN ATTACHING THIS PRODUCT TO THE NEEDLESS ADAPTER TIGHTLY AND THE VACUTAINER TUBE INSERTED, THERE IS NO SUCTION. THEY TRIED TO USE IT MULTIPLE TIMES DURING BLOOD WORK. SHE SAID THAT IT OCCURED WITH ROUGHLY 10 PATIENTS, NO SPECIFIC PROVIDED. THIS WAS THE FIRST TIME USING THE ADAPTER. NO HARM TO ANY PATIENT HOWEVER, THERE WAS A DELAY IN TREATMENT. POSSIBLE LOFF OF IU SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958980 SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER LUER LOCK ADAPTER JKA SOL-MILLENNIUM MEDICAL INC. 110201050003 05109110 00818392018158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown