BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19284931 · Received May 10, 2024

    Report

    Report Number
    8021545-2024-00320
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Report Date
    July 24, 2024
    Product Code
    FPA
    UDI-DI
    05705244022836
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 8021545-2024-00320. 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 FOLLOWING TESTS WERE COMPLETED FOR (B)(4) OF LOT 6003163: 1. VISUAL INSPECTION. (B)(4) WERE VISUALLY INSPECTED AND NO DAMAGES OR BENT. 2. (B)(6), FLOW TEST ON CUSTOMER COMPLAINTS -(B)(6), VERSION 10. (B)(4) MET THE CRITERIA OF MINIMUM 30ML/MINUTE BUT IN (B)(4) THE P-CAP CONNECTOR NEEDLE WAS CLOGGED (BY INSULIN). 3. (B)(6) LEAK TEST IN WATER, VERSION 44. (B)(4) NO AIR BUBBLES BURSTING DURING THE TEST TIME OF 30 SECONDS. FLOW TEST VALUES ON RETURNED USED DEVICES: P2: 53. P4: 65. FLOW TEST VALUES ON REFERENCE SAMPLES: P1: 45. P2: 58. P3: 47. P4: 52. P5: 45.

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 4.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 09-APR-2024, IT WAS REPORTED THAT THE PATIENT FACED LEAKAGE AT SITE ON 21-MAR-2024, 24-MAR-2024, 28-MAR-2024, 30-MAR-2024 AND 09-APR-2024. MOREOVER, THE ISSUE OCUURED WITH FOUR INFUSION SETS USED FOR ONE TO TWO DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127356 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 10PK INT FPA 6003163 05705244022836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown