MIO ADVANCE
Report
- Report Number
- 8021545-2025-02933
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- October 1, 2025
- Report Date
- April 7, 2026
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K173879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA.
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: REVIEW OF COMPLAINT RECORD DATABASE (B)(4) EVENT DESCRIPTION AND ALL AVAILABLE INFORMATION WAS COMPLETED, AND LOT NUMBER 6011536 WAS PROVIDED. COMPLAINT WAS CLASSIFIED UNDER MALFUNCTION CODE: INFUSION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS. A QUERY WAS RUN IN THE ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) ON 27-MAR-2026 AGAINST "LOT NUMBER" "6011536" AND SIMILAR MALFUNCTION CODES INFUSION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS. INFUSION SITE LEAKAGE - TRACE MOISTURE / SUPERFICAL WETNESS. INFUSION SITE LEAKAGE - TRACE MOISTURE / SUPERFICAL WETNESS. LEAKAGE INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). NO RECORDS WERE IDENTIFIED FOR THIS LOT AND SIMILAR RELATED ISSUES. A NON-CONFORMANCE (NC)/CORRECTIVE AND PREVENTIVE ACTION (CAPA) QUERY SEARCH WAS RUN IN THE EQMS SYSTEM PERFORMED ON 27-MAR-2026 AGAINST "LOT/BATCH NUMBER" "6011536". NO RECORDS WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW: THE DEVICE HISTORY RECORD (DHR) FOR LOT 6011536 WAS REVIEWED. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION OF COMPLAINT INVESTIGATION: LOT NUMBER 6011536 WAS PROVIDED, HOWEVER, AS THE COMPLAINT IS CATEGORIZED AS A REPORTABLE WITH NO HARM REPORTED AND NO ISSUES WERE FOUND DURING EQMS SEARCH AND DHR REVIEW: NO VISUAL INSPECTION IS REQUIRED TO BE PERFORMED. NO RETAIN SAMPLE TESTING IS REQUIRED TO BE CONDUCTED. NO FURTHER ASSESSMENT WILL BE MADE REGARDING POTENTIAL PRODUCT PERFORMANCE ISSUES, COMPONENT INTEGRITY, OR MANUFACTURING DEFECTS. CAPA DETERMINATION: BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION IS REQUIRED NOR CAPA PLAN IS NEEDED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING (MONTHLY TRIPS AND ALERTS). SUMMARY CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION HAS BEEN PERFORMED, AND THE COMPLAINT COULD NOT BE CONFIRMED AS ANALYZED. THEREFORE, THE COMPLAINT IS CLOSED BASED ON THE EVENT DESCRIPTION AND ALL INFORMATION MADE AVAILABLE.
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.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS IN THE ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330032 | MIO ADVANCE | UNO MIO ADV. GREY 60/6 SC1 10-PK CAN | FPA | UNOMEDICAL A/S | MMT-242A600 | 6011536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |