BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSOURCE

    MDR report key: 6728260 · Received July 18, 2017

    Report

    Report Number
    MW5071099
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    July 18, 2017
    Report Date
    July 18, 2017
    Manufacturer
    MEDSOURCE
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INADEQUATE/UNGLUED/UNSEALED CONNECTION BETWEEN THE EXTENSION TUBING AND MALE LUER LOCK ADAPTER. IV FLUIDS LEAK, AND TUBING MAY EASILY SEPARATE FROM ADAPTER. MEDSOURCE MS-83092 8" (20CM) NEEDLESS EXTENSION SET. LOT # 1500740. MFG DATE 201701. EXP DATE 202112. PERSONNEL DISCOVERED THE DEFECTIVE PRODUCT WHILE PREPARING THE IV ADMINISTRATION SET, PRIOR TO PATIENT CONTACT. SPECIFICALLY, THE DEFECT WAS DISCOVERED WHILE PRIMING THE TUBE WITH NORMAL SALINE. THIS SAME DEFECT HAD BEEN REPORTED ON A PREVIOUS ENCOUNTER BY ANOTHER EMPLOYEE, HOWEVER IT HAD BEEN MISUNDERSTOOD. IT WAS BELIEVED THE EMPLOYEE WAS REPORTING LEAKING AROUND THE UPPER FEMALE ADAPTER VALVE, WHICH CAN BE DISCONNECTED. THE EMPLOYEE IN THE PRIOR INCIDENT WAS ADVISED TO VERIFY THE FEMALE ADAPTER VALVE IS SECURELY FASTENED TO THE TUBING PRIOR TO USE. AFTER THE ABOVE OCCURRENCE, THE EMPLOYEE FROM THE PRIOR OCCURRENCE REAFFIRMED THAT LEAKING WAS EXPERIENCED BETWEEN THE TUBING AND MALE LUER LOCK ADAPTER. WHILE REMOVING THE PRODUCT FROM OUR INVENTORY, WE DISCOVERED SOME OLDER PRODUCT. THE OLDER PRODUCT HAD IDENTIFICATION MARKINGS OF: LOT 1500640. MFG DATE 201609. EXP DATE 202109. A CURSORY TEST OF THIS OLDER/OTHER LOT DID NOT REVEAL THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501008 MEDSOURCE MEDSOURCE LHI MEDSOURCE MS-83092 1500740

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR