BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19785648 · Received July 19, 2024

    Report

    Report Number
    8021545-2024-02336
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 15, 2024
    Report Date
    October 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023314
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 3 OF 3. E1: PATIENT CITY: (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 8021545-2024-02336. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND DEVICE MANUFACTURER DATE UNDER H4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002871 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH[?]WORK INSTRUCTION (WI) GUIDELINE FOR TEST OF REFERENCE SAMPLES VERSION 11 FOR THE MALFUNCTION LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WI VERSION 15 QUALITY SPECIFICATION - INSET GUARD RAMP-UP & INSET GUARD EWIS. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WI VERSION 10 FLOW TEST ON CUSTOMER COMPLAINTS -PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE.DOC. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WI VERSION 25 INSTRUCCIONES PARA EL USO DEL EQUIPO DE FUGA EN EL AREA DE INSPECCION.DOC. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6002871 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 14 ON THE PACKING PROCESS IN THE MACHINE SL01 / LINE MV11, ON 01/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY REPORT (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 8021545-2024-02336. 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: THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6002871 IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODELEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH VERSION 15 QUALITY SPECIFICATION - INSET GUARD RAMP-UP & INSET GUARD EWIS. TEST ON RETURNED REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO VERSION 10 FLOW TESTS IN CUSTOMER COMPLAINTS.DOC (PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE.DOC) TEST ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO VERSION 25 INSTRUCTIONS FOR USING LEAK DETECTION EQUIPMENT IN THE INSPECTION AREA.DOC (PRUEBAS DE FLUJO EN QUEJAS DEL CLIENTE.DOC) TEST ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. BATCH REVIEW: THE LOT 6002871 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 14 ON THE PACKING PROCESS IN THE MACHINE SL01 / LINE MV11, ON 22/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED 3 EXTENDED INFUSION SET LEAKAGE AT SITE AFTER TWO DAYS EVENT ON 15-JUN-2024. EXTENDED INFUSION SET HAS BEEN USED FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

    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
    1556308 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 3-PK INT FPA UNOMEDICAL A/S MMT-442AH 6002871 05705244023314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown