BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP INSET

    MDR report key: 21372361 · Received February 13, 2025

    Report

    Report Number
    3003442380-2025-01514
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 15, 2025
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). A COMPLAINT WAS RECEIVED FOR THE INSET II PRODUCT. HOWEVER, THE LOT NUMBER WAS NOT PROVIDED, WHICH LIMITS TRACEABILITY, AND NO SAMPLES ARE AVAILABLE FOR TESTS. INVESTIGATION ACTIONS WERE INITIATED TO ASSESS CURRENT CONTROLS AND IDENTIFY POTENTIAL RISKS. PACKAGING CONTROLS REVIEW: A LIST OF EXISTING PACKAGING CONTROLS IN THE INSET II MANUFACTURING PROCESS IS BEING COMPILED TO DOCUMENT HOW PACKAGING INTEGRITY ISSUES AND RELATED DEFECTS ARE CURRENTLY DETECTED AND PREVENTED. THESE INSPECTIONS ARE DOCUMENTED IN THE PFMECA 4906008 [68] OF THE INSET PACKAGING. SEE ATTACHED THE MEMO QUALITY CONTROLS IN THE ASSEMBLY PROCESS OF INSET PRODUCTS OF THE DHF 13 & DHF 14. ADDITIONALLY, DOC. NO. 4902036 OUTGOING FINAL INSPECTION FOR YPSOMED VISUAL INSPECTION BEFORE STERILIZATION - PACKAGING INSPECTION TEST NO. 4. 4.- VERIFY NEXT THAT INDIVIDUAL SET ACCORDING WHIT DOCUMENT (B)(4): * PROPERLY LID ASSEMBLY. * PROPERLY NEEDLE PROTECTOR ASSEMBLY. * INFORMATION LEGIBLE ON LID THE PRODUCT. * PROPERLY ASSEMBLY OF THE SLEEVE. ACCORDING TO DOC. (B)(4): * WITHOUT DOUBLE TYVEK. * TYVEK PROPERLY WELDED. * THERE MUST NOT BE FIRM LESS/LOOSE OR FOREIGN OBJECTS INSIDE THE PACKAGES. * AMONG OTHERS POINTS TO VERIFY ACCORDING WITH DOCUMENT (B)(4). CONCLUSION: ALTHOUGH THE LOT NUMBER AND PHYSICAL SAMPLES ARE UNAVAILABLE, THE INVESTIGATION INCLUDES A COMPREHENSIVE REVIEW OF CURRENT CONTROLS TO ENSURE PACKAGING INTEGRITY AND COMPLIANCE WITH ESTABLISHED STANDARDS.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET PACKAGING ISSUE ON (B)(6) 2025. IT WAS REPORTED THAT THE CATHETER PACK 6/46 WAS OPEN. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108030 YPSOPUMP INSET UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL UM-D 86-046-52B6 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown