INSET
Report
- Report Number
- 3003442380-2025-14753
- Event Type
- Injury
- Date Received
- October 7, 2025
- Date of Event
- September 9, 2025
- Report Date
- October 7, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244016682
- PMA / PMN Number
- K032854
- 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 6010619, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26-SEP-2025 AGAINST "FINAL REPORTING DECISION" EQUAL "SERIOUS INJURY AND DEATH", "LOT NUMBER" CRITERIA EQUAL LOT NUMBER "6010619". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010619 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND PACKAGED IN THE LINEA 07 ON 07-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 4M01057 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 2.0 AND MANUFACTURED IN THE MACHINE ITL03, ON 05-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 4M00919 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 2.0 AND MANUFACTURED IN THE MACHINE ITL03, ON 04-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 4K04747 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 65.0 AND MANUFACTURED IN THE MACHINE SC03, ON 21-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND - (WI) GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TEST OF REFERENCE SAMPLES, 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 IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE. CAPA DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES" AND WILL COVER INSET I (AUTOSOFT XC DHF-13.8 & 13.13) AND INSET II (AUTOSOFT 90 DHF-14 AND 14.3) PRODUCTS. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE HAS BEEN IDENTIFIED AS: METHOD, MANPOWER, MEASUREMENT, MACHINE: CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: THE ACTION PLAN AND DEADLINES IS AS FOLLOWED: THE FOLLOWING ACTIONS WERE ALREADY IMPLEMENTED IN THE NON-CONFORMANCE (NC). 1. INCLUDE THE DEFECT IN DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) 2. IMPROVE GUARDS OF THE CONVEYORS . 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS . 4. UPDATE DOCUMENT (B)(4) (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. 5. UPDATE THE DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) TO INCLUDE THE PREVENTIVE ACTIONS IMPLEMENTED IN THE PROCESS (TRAYS) A REMAINING ACTION (TO ADDRESS DESIGN ROOT CAUSE) AND DEADLINES IS AS FOLLOWED: ADD CYLINDERS TO THE LID TO MAINTAIN IN POSITION THE NEEDLE AND CANNULA DURING TRANSPORTATION AND PRIOR USE (DATABASE (B)(4) (B)(6) 2025)."
CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER. 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 6010619, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26-SEP-2025 AGAINST "FINAL REPORTING DECISION" EQUAL "SERIOUS INJURY AND DEATH", "LOT NUMBER" CRITERIA EQUAL LOT NUMBER "6010619". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010619 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND PACKAGED IN THE LINEA 07 ON 07-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 4M01057 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 2.0 AND MANUFACTURED IN THE MACHINE ITL03, ON 05-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 4M00919 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 2.0 AND MANUFACTURED IN THE MACHINE ITL03, ON 04-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 4K04747 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 65.0 AND MANUFACTURED IN THE MACHINE SC03, ON 21-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: - (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND - (WI) GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TEST OF REFERENCE SAMPLES, 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 IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES" AND WILL COVER INSET I (AUTOSOFT XC DHF-13.8 & 13.13) AND INSET II (AUTOSOFT 90 DHF-14 AND 14.3) PRODUCTS. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE HAS BEEN IDENTIFIED AS: METHOD, MANPOWER, MEASUREMENT, MACHINE: CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: THE ACTION PLAN AND DEADLINES IS AS FOLLOWED: THE FOLLOWING ACTIONS WERE ALREADY IMPLEMENTED IN THE NON-CONFORMANCE (NC) · 1. INCLUDE THE DEFECT IN DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) · 2. IMPROVE GUARDS OF THE CONVEYORS · 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS · 4. UPDATE DOCUMENT (B)(4) (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. · 5. UPDATE THE DOCUMENT (B)(4) (WORK INSTRUCTION INSET LINE) TO INCLUDE THE PREVENTIVE ACTIONS IMPLEMENTED IN THE PROCESS (TRAYS) A REMAINING ACTION (TO ADDRESS DESIGN ROOT CAUSE) AND DEADLINES IS AS FOLLOWED: · ADD CYLINDERS TO THE LID TO MAINTAIN IN POSITION THE NEEDLE AND CANNULA DURING TRANSPORTATION AND PRIOR USE (DATABASE (B)(4) - (B)(6) 2025)."
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT WENT TO EMERGENCY ROOM (ER) ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 487 MG/DL AND WAS CAUSED BY BENT CANNULA EVENT. THE INSERTION SITE WAS ABDOMEN. PATIENT WAS FOUND POSITIVE FOR HIGH KETONES LEVEL AND KETONE LEVELS WERE FOUND TO BE LIFE-THREATENING. THE PATIENT WAS ALSO HAVING SYMPTOMS OF STOMACH ACHE, NUMBNESS OF FACE AND MOUTH, THROWING UP AND DEHYDRATION. STRESS ALSO TRIGGERED SHINGLES AND PATIENT WAS ON ANTIBIOTIC MEDICATION. THE DURATION OF EMERGENCY ROOM STAY WAS 12 HOURS. PATIENT WAS RELEASED FROM EMERGENCY ROOM ON (B)(6) 2025. 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 |
|---|---|---|---|---|---|---|---|
| 2692488 | INSET | UNO INSET I 60/6 PINK TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 1001682 | 6010619 | 05705244016682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Life Threatening| R |