MEDTRONIC EXTENDED INFUSION SET
Report
- Report Number
- 8021545-2024-02122
- Event Type
- Malfunction
- Date Received
- July 15, 2024
- Date of Event
- June 14, 2024
- Report Date
- May 13, 2025
- 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
PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA.
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.
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. THE REFERENCE SAMPLES FOR THE LOT 6003885 HAVE BEEN TESTED IN THE TRACKWISE RECORD (B)(4) ON 13-MAY-2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND FUNCTIONALLY PULL (TENSILE) TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE DATABASE (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003885 WAS MANUFACTURED ACCORDING TO 3902085 VERSION 79 APPENDIX 1 BATCH CARD FOR PRODUCTION OF PACKAGING ROOM, ON 02-NOV-2023, WITH A TOTAL OF (B)(4) UNITS. 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. TRENDING: A QUERY WAS RUN IN DATABASE ON 13-MAY-2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6003885 WITH OTHER COMPLAINTS IDENTIFIED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H11: INVESTIGATION SUMMARY: THE FOLLOWING TESTS WERE COMPLETED FOR 5 REFERENCE SAMPLES DEVICE OF LOT 6003885: 1. VISUAL INSPECTION AS PER 4A02031 INSET I INSET GUARD CONNECTOR ENGLISH SPANISH VERSION 12. 5 REFERENCE SAMPLES VISUALLY INSPECTED NO DEVIATIONS WERE IDENTIFIED. 2. 4802104, INSTRUCTIONS FOR STATIC PULL, VERSION 45. 5 REFERENCE SAMPLES WERE TESTED ON STATIC PULL TUBING-TUBING-CONNECTOR, NO DEVIATIONS WERE IDENTIFIED.
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET TUBING WAS DETACHED FROM THE TUBING CONNECTOR AT THE TIME OF SLEEPING WITHIN 3 DAYS OF USE. INFUSION SET WAS PLACED IN UPPER RIGHT LEG. NO FURTHER INFORMATION WAS AVAILABLE.
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.
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 |
|---|---|---|---|---|---|---|---|
| 1392261 | MEDTRONIC EXTENDED INFUSION SET | UNO EWIS BLUE 80/9 HCAP 3-PK INT | FPA | UNOMEDICAL A/S | MMT-442AH | 6003885 | 05705244023314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |