BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPC-130

    MDR report key: 24318216 · Received February 11, 2026

    Report

    Report Number
    1932668-2026-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    November 21, 2025
    Report Date
    February 9, 2026
    Manufacturer
    MOLDED PRODUCTS INC
    Product Code
    FPA
    UDI-DI
    B144MPC1300
    PMA / PMN Number
    K925927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INCLUDED EVALUATION OF CUSTOMER-RETURNED PRODUCT, IN-STOCK PRODUCT FROM A DIFFERENT LOT, REVIEW OF PRODUCTION AND ASSEMBLY RECORDS, TRAINING RECORDS, RAW MATERIAL DOCUMENTATION, PRODUCT DESIGN, AND CUSTOMER-SUPPLIED INFORMATION. THE REVIEW DETERMINED THAT THE PRODUCT WAS MANUFACTURED USING APPROVED MATERIALS AND MET APPLICABLE SPECIFICATIONS. NO DEFICIENCIES WERE IDENTIFIED WITH RAW MATERIALS, EQUIPMENT PERFORMANCE, DESIGN, OR PRODUCTION DOCUMENTATION. HOWEVER, THE INVESTIGATION CONFIRMED THAT THE PRODUCT WAS NOT ASSEMBLED IN ACCORDANCE WITH THE ESTABLISHED ASSEMBLY PROTOCOL. ADDITIONALLY, A LACK OF DOCUMENTED TRAINING SPECIFIC TO THE ASSEMBLY PROCESS WAS IDENTIFIED. THE NON-CONFORMANCE WAS ATTRIBUTED TO INSUFFICIENT TRAINING AND FAILURE TO ADHERE TO THE APPROVED ASSEMBLY PROTOCOL. CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED TO ADDRESS TRAINING DOCUMENTATION REQUIREMENTS AND TO REINFORCE COMPLIANCE WITH THE ESTABLISHED ASSEMBLY PROCEDURES TO PREVENT RECURRENCE.

    Description of Event or Problem · 0

    CLINIC PERSONNEL NOTED ON (B)(6) 2025 WHILE REMOVING THE SEE LUER CAP SET MPC-130 FROM ITS BAG, THAT THE THREADED SLEEVE WAS NOT ENGAGED WITH THE LUER PIN.THE HEALTH WORKER SET ASIDE THE PART AND OBTAINED A NEW PART. NO DIRECT PATIENT INVOLVEMENT WAS NOTED. THIS EVENT WAS REPORTED TO MOLDED PRODUCTS 12/08/2025 AN INVESTIGATION WAS IMMEDIATELY OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376094 MPC-130 SEE LUER CAP SET FPA MOLDED PRODUCTS INC 20389 B144MPC1300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown