QUICK SET
Report
- Report Number
- 3003442380-2025-16721
- Event Type
- Malfunction
- Date Received
- November 19, 2025
- Date of Event
- November 3, 2025
- Report Date
- March 31, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244017450
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION.
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.
CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED 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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 05-MAR-2026 AGAINST LOT NUMBER 6012105 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE REVIEW CONFIRMED THAT LOT 6012105 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 05-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012105 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012105 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 11-MAR-2025 WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY OF THE LOT 5C00140 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN QUICKSET LINE, ON 11-MAR-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY OF THE LOT 5C00139 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN QUICKSET LINE, ON 10-MAR-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY OF THE LOT 5C00141 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN QUICKSET LINE, ON 11-MAR-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5C00159 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04 & MP08, ON 09-MAR-2025, WITH A TOTAL OF (B)(4). THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5B04989 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04 & MP08, ON 07-MAR-2025, WITH A TOTAL OF (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT ALL REQUIRED IN PROCESS INSPECTIONS AND FINAL PRODUCT TESTS WERE COMPLETED. DURING OUTGOING TEST 9, ONE SAMPLE WAS OBSERVED WITH RELEASE LINER DELAMINATES FROM ADHESIVE PATCH; HOWEVER, THIS FINDING IS WITHIN THE ACCEPTABLE LIMITS PER AQL CRITERIA AND DOES NOT REQUIRE FURTHER ACTION. NO DEVIATIONS, NONCONFORMANCES, OR EQUIPMENT RELATED MAINTENANCE EVENTS WERE IDENTIFIED THAT CORRELATE WITH THE REPORTED COMPLAINT CONDITION. CONCLUSION: NO MANUFACTURING ISSUES WERE IDENTIFIED, AND THE CONTAMINATED SAMPLE WAS ACCEPTABLE PER AQL. RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): ALL 3 SAMPLES TESTED PASSED FUNCTIONAL STATIC PULL OF THE TUBING-TUBING CONNECTOR FOR THE REPORTED MALFUNCTION CODE LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4) TEST REPORT. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE RETURNED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): THE RETURNED USED TUBING WAS INSPECTED IN RELATION TO THE REPORTED MALFUNCTION CODE LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS. THE TUBING WAS FOUND DETACHED FROM THE TUBING-TUBING CONNECTOR. DUE TO THIS CONDITION, FUNCTIONAL TESTS SUCH AS THE STATIC PULL TEST COULD NOT BE PERFORMED. ALL TEST RESULTS WERE DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT 2445355 TEST REPORT. CONCLUSION: VISUAL INSPECTION CONFIRMED THE REPORTED ISSUE; ESCALATION FOR CAPA AND FURTHER INVESTIGATION REQUIRED PER QUALITY PROCEDURES. STATISTICAL ANALYSIS RESULT: AFTER ASSESSMENT OF THE FAILURE VIA PRODUCT TRENDING OVER TIME, REFER TO ATTACHMENT FORM MMT-399A SIGNED WITH CONTROL CHARTS, THE RISK HAS BEEN DEEMED AS WITHIN ACCEPTED LIMITS. NO FURTHER ACTION IS REQUIRED. COMPLAINT CONFIRMED: FOLLOWING THE INVESTIGATION, THE REPORTED FAILURE HAS BEEN CONFIRMED FOR THIS COMPLAINT. THE COMPLAINT WAS CONFIRMED BASED ON THE INSPECTION OF THE RETURNED TUBING, WHICH IDENTIFIED THE FAILURE MODE AS LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT/SIGNIFICANT WETNESS. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: THE INVESTIGATION INCLUDED A COMPREHENSIVE REVIEW OF EQMS RECORDS, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD VERIFICATION, AND ASSESSMENT OF THE VISUAL EVIDENCE PROVIDED. NO NCRS, CAPAS, OR QUALITY EVENTS OF THE SAME OR SIMILAR NATURE WERE IDENTIFIED FOR LOT 6012105 OR THE ASSOCIATED MALFUNCTION CODE. LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS. THE RETURNED USED TUBING WAS INSPECTED IN RELATION TO THE REPORTED MALFUNCTION CODE. THE TUBING WAS FOUND DETACHED FROM THE TUBING-TUBING CONNECTOR. ALL AVAILABLE DOCUMENTATION AND ANALYSIS INDICATE THAT THE ISSUE IS ISOLATED AND NOT LINKED TO SYSTEMIC MANUFACTURING OR QUALITY CONCERNS. STATISTICAL EVALUATION AND PRODUCT FAMILY TRENDING CONFIRMED THAT THE RISK ASSOCIATED WITH THIS MALFUNCTION REMAINS WITHIN ACCEPTABLE LIMITS. BASED ON THESE FINDINGS, NO ADDITIONAL INVESTIGATION OR CORRECTIVE ACTIONS ARE REQUIRED. THE RECORD WILL BE CLOSED AND WILL CONTINUE TO BE MONITORED THROUGH ROUTINE TRACKING AND TRENDING ACTIVITIES.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2025 DUE TO WHICH PATIENT FACED HYPERGLYCEMIA EVENT. THE SITE OF DETACHMENT WAS CLOSE TO SITE LOCATION. THE INFUSION SET WAS IN USE FOR THREE DAYS. 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 |
|---|---|---|---|---|---|---|---|
| 171063 | QUICK SET | UNO QUICK-SET 60/6 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-399A | 6012105 | 05705244017450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |