SILHOUETTE PARADIGM
Report
- Report Number
- 3003442380-2024-29910
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Date of Event
- September 30, 2024
- Report Date
- February 13, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K162812
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED LOT NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 6000950 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 1 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE TUBING CONNECTOR DETACHED FROM INFUSION SET. 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 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL CLICK BETWEEN CONNECTOR AND CANNULA STATIC PULL TEST 1 ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000950 WAS PACKAGING ACCORDING TO THE WI VERSION 14, IN THE MULTIVAC M10, ON 18/APR/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3CO3731 WAS GLUED ACCORDING TO THE WI VERSION 9, MACHINE LC02, ON 23 MARCH 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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 10/FEB/2025 AGAINST MALFUNCTION CODE TUBING CONNECTOR FROM INFUSION SET AND LOT 6000950 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6000950 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: SERTER RETURNED SHOWS NO DAMAGES OR DEFECTS. NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM REPORTABLE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO THE MALFUNCTION REPORTED, OTHER 1 COMPLAINT 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.
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT FROM NEEDLE AND TUBE ON (B)(6) 2024. THE INSERTION SITE WAS AT RIGHT ABDOMEN AND THE SET WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021346 | SILHOUETTE PARADIGM | UNO COMFORT 60/17 SC1 MCNI | FPA | UNOMEDICAL A/S | MMT-378A600 | 6000950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |