QUICK SET
Report
- Report Number
- 3003442380-2025-16887
- Event Type
- Injury
- Date Received
- December 8, 2025
- Date of Event
- March 11, 2025
- Report Date
- January 11, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244017931
- PMA / PMN Number
- K160648
- Adverse Event
- 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. ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 11/JAN/2026 AGAINST LOT NUMBER 6012112 AND SIMILAR MALFUNCTION CODES: COMPONENT DEFECT- DIFFICULT OR UNABLE TO CONNECT/DISCONNECT / RE-CONNECT SITE CONNECTOR TO CANNULA HOUSING, DIFFICULT OR UNABLE TO CONNECT/RE-CONNECT TUBING CONNECTOR TO INFUSION SET (CANNULA PART/BASE PIECE), DIFFICULT OR UNABLE TO DISCONNECT TUBING CONNECTOR FROM INFUSION SET. (CANNULA PART/BASE PIECE). THE REVIEW CONFIRMED THAT LOT 6012112 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 11/JAN/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6000249 AND SIMILAR MALFUNCTION CODES:COMPONENT DEFECT- DIFFICULT OR UNABLE TO CONNECT/DISCONNECT / RE-CONNECT SITE CONNECTOR TO CANNULA HOUSING, DIFFICULT OR UNABLE TO CONNECT/RE-CONNECT TUBING CONNECTOR TO INFUSION SET (CANNULA PART/BASE PIECE), DIFFICULT OR UNABLE TO DISCONNECT TUBING CONNECTOR FROM INFUSION SET. (CANNULA PART/BASE PIECE). THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS (B)(4). DHR REVIEW: THE LOT 6012112 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 13/MAR/2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 5C00153 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN QUICKSET LINE, ON 13/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 5B02952 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN QUICKSET LINE, ON 14/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5C00164 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04 & MP08, ON 12/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5B04988 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) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5B00443 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04 & MP08, ON 10/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. DHR REVIEW: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. 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 THE STATIC PULL OF THE TUBING-TUBING CONNECTOR FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE COMPONENT DEFECT- DIFFICULT OR UNABLE TO CONNECT/ DISCONNECT / RE-CONNECT SITE CONNECTOR TO CANNULA HOUSING. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. CONCLUSION: VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO LACK OF SAMPLE AVAILABILITY. ASSESSMENT WILL BE BASED ON OTHER AVAILABLE EVIDENCE. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6012112 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING. FOR MORE DETAILS, SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4).
E1: PATIENT CITY:(B)(6) PATIENT COUNTRY: BRAZIL 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 BRAZIL IT WAS REPORTED THAT THE PATIENT FACED SEVERE HYPERGLYCEMIA EVENT AND PROGRESSED TO DIABETIC KETOACIDOSIS (DKA) DUE TO TUBING DETACHMENT FROM THE QUICK RELEASE (QR) CONNECTION POINT AND WAS HOSPITALIZED ON (B)(6) 2025 AND REMAINED THERE FOR ONE DAY. THE BLOOD GLUCOSE (BG) LEVEL AT THE TIME OF ADMISSION WAS 400 MG/DL WITH SYMPTOMS OF MENTAL CONFUSION, NAUSEA, HEADACHE, FATIGUE/WEAKNESS, BLURRED VISION, PAIN/CRAMPS IN THE EXTREMITIES, AND EXCESSIVE THIRST. THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL WAS STABILIZED AT 120 MG/DL AFTER THE DISCAHRGE. NO FURTHER INFORMATION AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2437968 | QUICK SET | UNO QUICK-SET 110/6 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-398A | 6012112 | 05705244017931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |