QUICK-SET
Report
- Report Number
- 3003442380-2025-14748
- Event Type
- Injury
- Date Received
- October 10, 2025
- Date of Event
- September 11, 2025
- Report Date
- October 9, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- K160648
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.
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: THE REFERENCE SAMPLES FOR THE LOT 6011035 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINTS (B)(4) ON 26-SEP-2025. A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011035, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-SEP-2025 AGAINST "FINAL REPORTING DECISION" EQUAL "SERIOUS INJURY AND DEATH", "LOT NUMBER" CRITERIA EQUAL LOT NUMBER "6011035". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011035 WAS PACKAGED ACCORDING TO THE WI VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 12-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) (B)(4) SEVERAL LOCATIONS OOS IN PARTICLE COUNTING FROM CLEANROOM 2 AND CLEANROOM 4. THE SUB-ASSEMBLY: THE TUBING LOT 5A01013 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, ON 12-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE TUBING LOT 5A01014 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, ON 12-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. THE TUBING LOT 5A01015 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, ON 12-JAN-2025, 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: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST, FUNCTIONAL TEST AIR LEAK ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST, ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES. ONE NON-CONFORMANCE (NC) WAS RAISED DURING PRODUCTION FOR PARTICLE COUNTING NO RELATED TO COMPLAINT CODE REPORTED, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HYPERGLYCEMIA EVENT ON (B)(6) 2025. PATIENT HAS NOT BEEN RELEASED FROM THE HOSPITAL YET. 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 |
|---|---|---|---|---|---|---|---|
| 311936 | QUICK-SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-397A | 6011035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |