INSET
Report
- Report Number
- 3003442380-2025-17734
- Event Type
- Injury
- Date Received
- December 30, 2025
- Date of Event
- October 31, 2025
- Report Date
- January 14, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 14-JAN-2026 AGAINST "LOT NUMBER 6013172 AND SIMILAR MALFUNCTION CODE(S): SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE REVIEW CONFIRMED THAT LOT 6013172 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 14-JAN-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013172 AND SIMILAR MALFUNCTION CODES SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE COUNT OF COMPLAINT IS 4. THE COMPLAINT NUMBERS ARE (B)(4). CONCLUSION: AFTER REVIEW, ONLY (B)(4) WAS DETERMINED RELEVANT TO THE REPORTED ISSUE. THE OTHER THREE RECORDS WERE PREVIOUSLY CLOSED AND ARE NOT APPLICABLE TO THIS INVESTIGATION DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013172 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 123 AND MANUFACTURED IN THE L9 LI94, ON 19-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 6 (OTHERS), ONE SAMPLE WAS FOUND WITH DAMAGED PROTECTOR. AN EXTENDED SAMPLING WAS CONDUCTED AND ACCEPTED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION 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 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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: AS A RESULT OF THE FOLLOWING: 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 6013172 AND RELATED MALFUNCTION CODES. FOUR COMPLAINTS WERE 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.
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 THE PATIENT FACED KINKED CANNULA EVENT DUE TO WHICH THE PATIENT FACED HYPERGLYCEMIA EVENT ON (B)(6) 2025. THE EVENT OCCURRED WITHIN THREE OR MORE HOURS AFTER INSERTION.THE INSERTION SITE WAS ABDOMEN.THE INFUSION SET WAS IN USE FOR 15 HOURS. THE BLOOD GLUCOSE LEVEL WAS 623 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). THE PATIENT HAD KETONES WHICH WAS LIFE THREATENING.THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2197388 | INSET | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 1001680 | 6013172 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Male | Required Intervention| L |