COMFORT
Report
- Report Number
- 3003442380-2025-14719
- Event Type
- Malfunction
- Date Received
- October 8, 2025
- Date of Event
- April 9, 2025
- Report Date
- November 6, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- 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 COMMON DEVICE NAME UNDER D2 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 UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010850 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010850 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 20 AND PACKAGING IN THE MULTIVAC 14, ON 20/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 4G05826 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32 WELDING IN THE MACHINE LS25, ON XX/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 4K02664 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS25, ON XX/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 4L06310 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24, ON XX/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 4H00313 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24, ON XX/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 4M02977 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24, ON XX/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBING THE LOT 4M03550 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON XX/AUG/202, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBING THE LOT 4M03550 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON XX/AUG/202, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBING THE LOT 4M03550 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON XX/AUG/202, 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 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.
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: POLAND.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET'S TUBING DETACHMENT EVENT ON (B)(6) 2025. THE DETACHMENT WAS FROM SITE CONNECTOR. THE EVENT OCCURRED WHILE THE PATIENT WAS ASLEEP. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2586874 | COMFORT | UNO COMFORT SHORT 60/13 SC1 MIN | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-381A | 6010850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |