INSET
Report
- Report Number
- 3003442380-2025-19170
- Event Type
- Malfunction
- Date Received
- January 22, 2026
- Date of Event
- November 23, 2025
- Report Date
- February 11, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244016651
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
SUPPLEMENTAL REPORT 01- MDR (B)(4)- MDR 3003442380-2025-19170. 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 29-DEC-2025 AGAINST "LOT NUMBER 6013379 AND SIMILAR MALFUNCTION CODES PRIMARY PACK DEFECT - SEAL DEFECT. THE REVIEW CONFIRMED THAT LOT 6013379 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 29-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013379 AND SIMILAR MALFUNCTION CODES PRIMARY PACK DEFECT - SEAL DEFECT. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013379 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 123 AND MANUFACTURED IN THE LINE INSET 10 ON 21-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. 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. 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 6013379 AND RELATED MALFUNCTION CODES FOR PACKAGE ISSUE. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT 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. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.
INITIAL AND FINAL MDR (B)(4) - DEVICE 3 OF 3.
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 THREE INFUSION SET LEAKAGE EVENT WITHIN THE PAST WEEK. THE INFUSION SET WAS IN USE FOR LESS THAN 24 HOURS. IT WAS REPORTED THAT THERE WAS BLOOD INTO THE TUBING. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204433 | INSET | UNO INSET I 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 1001681 | 6013379 | 05705244016651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female |