TRUSTEEL
Report
- Report Number
- 3003442380-2024-37046
- Event Type
- Malfunction
- Date Received
- January 16, 2025
- Date of Event
- December 15, 2024
- Report Date
- June 20, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018457
- PMA / PMN Number
- K041545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REFERENCE SAMPLES FOR THE LOT 6001643 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND FOR FLOW (B)(4) ON (B)(6) 2024. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4) TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001643 WAS MANUFACTURED ACCORDING TO THE WI VERSION 91 MANUFACTURED IN THE MACHINE MULTIVAC 10, ON 01/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. WELDING LOT: THE LOT 3E05682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 MANUFACTURED IN THE MACHINE LS25, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 MANUFACTURED IN THE MACHINE LS11, ON 31/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E03389 WAS MANUFACTURED ACCORDING TO THE WI VERSION 64 MANUFACTURED IN THE MACHINE LS11, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR LOT: THE LOT 3E05019 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE MACHINE MP03, ON 30/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E05020 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE MACHINE MP03, ON 31/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04996 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE MACHINE MP03, ON 28/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04998 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE MACHINE MP03, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04999 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE MACHINE MP03, ON 29/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D00117 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 MANUFACTURED IN THE MACHINE MP03, ON 02/APR/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 WERE IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 17-JUN-2025 AGAINST MALFUNCTION CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6006114 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6006114 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINTS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS AT THE SITE. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1509128 | TRUSTEEL | UNO CONTACT DETACH G29 80/6TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002834 | 6001643 | 05705244018457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |