QUICK SET
Report
- Report Number
- 3003442380-2025-16191
- Event Type
- Injury
- Date Received
- November 11, 2025
- Date of Event
- October 21, 2025
- Report Date
- November 15, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K160648
- Adverse Event
- 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. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010403, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 14-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6010403". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. (B)(4). NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR)REVIEW: THE LOT 6010403 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE 12 ON 23-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 4L01886 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ON 22-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 4L01887 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ON 23-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 4L01880 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ON 23--NOV-2024, 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. TEST RESULTS: NO PHOTO WAS PROVIDED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 1 SAMPLE OUT 10 SAMPLES WERE FOUND WITH A DEFECTIVE TUBING CONNECTOR THE CLICK LEG WAS CLOSED, NO RELATION WITH MALFUNCTION CODE. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 1 SET WAS FOUND THE CONNECTOR THE CLICK LEG WAS CLOSED, NO RELATION WITH MALFUNCTION CODE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, TWO COMPLAINS THRESHOLD IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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: AUSTRALIA.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL WAS 32.7 MMOL/L AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS DRIP. THE LENGTH OF HOSPITALIZATION WAS LESS THAN 24 HOURS. THE PATIENT ALSO REPORTED SYMPTOMS AT THE TIME OF HOSPITALIZATION LIKE VOMITING. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185759 | QUICK SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-397A | 6010403 | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |