SURE-T PARADIGM
Report
- Report Number
- 3003442380-2025-01970
- Event Type
- Malfunction
- Date Received
- February 21, 2025
- Date of Event
- January 22, 2025
- Report Date
- April 29, 2025
- Manufacturer
- UNOMEDICAL UM-D
- Product Code
- FPA
- UDI-DI
- 05705244019317
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INITIAL AND FINAL MDR (B)(4). DEVICE 6 OF 6. E1:PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA.
SUPPLEMENTAL REPORT 01 - (B)(4) MDR 3003442380-2025-01969. 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6004330 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND 4802104 INSTRUCTIONS FOR STATIC PULL TEST.DOC VERSION 47 FOR THE CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL STATIC TEST OF THE TUBE TO THE MOLDING NEEDLE 1 ACCORDING TO WI VERSION 47 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING THE LOT 6004330 WAS MANUFACTURED ACCORDING TO THE WI VERSION 94 AND PACKAGING IN THE MULTIVAC 10, ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE LOT 3L02902 WAS MANUFACTURED ACCORDING TO THE WI VERSION 33 WELDING MACHINE LS24, LS25 & LS11 ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01691 WAS MANUFACTURED ACCORDING TO THE WI VERSION 33 WELDING MACHINE LS24, LS25 & LS11 ON 16/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01692 WAS MANUFACTURED ACCORDING TO THE WI VERSION 33 WELDING MACHINE LS05 & LS07 ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF CONNECTOR: THE LOT 3L01681 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 16/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L03055 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01683 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 18/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L02892 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 19/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 15/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. MOLDING: THE LOT 3L01661 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS19 ON 15/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01658 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS18 ON 15/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L02860 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS19 ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01660 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS18 ON 17/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L02859 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS18 ON 18/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L02882 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS19 ON 18/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3L01659 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE MOLDER MACHINE LS19 ON 13/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 24/APR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS AND LOT 6004330 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6004330 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON 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.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS NEEDLE BREAK ON (B)(6) 2025. THE EVENT OCCURRED DURING INSERTION. THE INFUSION SET WAS INSERTED IN THE BODY FOR COUPLE OF MINUTES. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1667548 | SURE-T PARADIGM | UNO CONTACT DETACH G29 60/6 SC1 MIMX | FPA | UNOMEDICAL UM-D | MMT-864A | 6004330 | 05705244019317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |