BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 3MLSFTY COMB 21X1 1/2

    MDR report key: 12819940 · Received November 16, 2021

    Report

    Report Number
    1017768-2021-00991
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Report Date
    February 4, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    UDI-DI
    50192253024706
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TEN UNUSED SAMPLES AND EIGHT PHOTOS WERE PROVIDED FOR EVALUATION. ALL SAMPLES WERE VISUALLY AND PHYSICALLY TESTED FOR HUB ISSUES AND NO FAILURES WERE FOUND. THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND AN EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. DURING THE MANUFACTURING PROCESS PRODUCTS WERE VISUALLY INSPECTED AND PHYSICALLY TESTED WITH NO FAILURES FOUND. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS SHOWED NO ISSUES RELATED TO THE REPORTED CONDITION. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED. THERE WERE NO PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT IN THE 12 MONTHS PRIOR TO THE PRODUCTION DATE. THE OEE DATA FOR THE ASSEMBLY MACHINES WERE REVIEWED FOR ALL RELATED THE PRODUCTION DATES AND NO EQUIPMENT ISSUES RELATED TO THE REPORTED CONDITION WERE OBSERVED. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. THE EQUIPMENT WAS REVIEWED FOR MALFUNCTIONS OR ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, BUT NO SUCH ISSUES WERE OBSERVED DURING THE REVIEW. A SEARCH OF THE NON-CONFORMANCE DATABASE WAS CONDUCTED FOR POTENTIAL ISSUES RELATED TO THE REPORTED CONDITION. THERE WERE NO NCRS ISSUED AGAINST THIS LOT OR SHIELD SUB LOTS FOR RELATED FAILURE. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE INSPECTED FOR ISSUES WITH THE HUB. THE SHOP ORDERS USED FOR THIS LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WERE RELEASED. THERE WERE NO ANOMALIES FOUND DURING A REVIEW OF THE DEVICE HISTORY RECORD, MAINTENANCE RECORDS OR PROCESS MONITORING DATA. THERE WAS NO EVIDENCE OF ANY SYSTEMIC FAILURE OF THE MANUFACTURING PROCESS. BASED ON THE INVESTIGATION AND ROOT CAUSE ANALYSIS, THE INITIATION OF A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE HUB CRACKED DURING DIRECT PATIENT CARE WHILE ADMINISTERING ANTIPSYCHOTIC INJECTIONS. THE PATIENT RECEIVED AN UNKNOWN AMOUNT OF MEDICATION (HALDOL). AS THE HALDOL WAS BEING ADMINISTERED IT LEAKED QUITE A BIT AND THEY WERE NOT ABLE TO GAUGE HOW MUCH WAS ACTUALLY ADMINISTERED. THE PATIENT REPORTED SOME PSYCHOTIC SYMPTOMS IN BETWEEN INJECTION TIME FRAMES AND HAD TO BE SUPPLEMENTED WITH ORAL ANTIPSYCHOTICS UNTIL THE NEXT INJECTION WAS DUE. NO ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721625 MAGELLAN 3MLSFTY COMB 21X1 1/2 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 8881833115 035729 50192253024706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other