CONTACT DETACH
Report
- Report Number
- 3003442380-2026-99800
- Event Type
- Malfunction
- Date Received
- March 26, 2026
- Date of Event
- October 12, 2023
- Report Date
- February 25, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V
- Product Code
- FPA
- UDI-DI
- 05705244019348
- PMA / PMN Number
- K041545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: POLAND. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 18-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. 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 17/MAR/2026 AGAINST LOT NUMBER 6000933 AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS THE REVIEW CONFIRMED THAT LOT AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCR - NON-CONFORMANCE REPORT OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 17/MAR/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6002435 AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS 1761143. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000933 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED IN THE M10 MACHINE ON 18-APR-2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY: LOT 3D01680 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 24 AND ASSEMBLED IN THE MACHINES LS06, LS07, LS24, LS25 ON 16-APR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D01686 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 55 AND ASSEMBLED IN MACHINE SC05, ON 17-APR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D00296 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND ASSEMBLED IN THE GLUEING 3 LINE ON 15-APR-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3D01676 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND ASSEMBLED IN THE GLUEING 3 LINE ON 16-APR-2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW CONFIRMED THAT LOTS 3D01680, 3D00296 AND 3D01676 WERE ASSOCIATED WITH CAPA 1658408 FOR DUPLICATE PRODUCTION ORDER. HOWEVER, THIS NON-CONFORMANCE IS NOT RELATED TO THE REPORTED FAILURE MODE AND IS NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. 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. COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 WORK INSTRUCTION (WI)(MONTHLY TRIPS AND ALERTS). THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 16-FEB-2026 UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE AND NEW REPORTABILITY REQUIREMENTS. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED ONE RELATED COMPLAINT FOR LOT 6000933. NO NCRS, CAPAS, TRENDS, OR SYSTEMIC ISSUES WERE FOUND. AS REQUIRED UNDER THE UPDATED REPORTABILITY CRITERIA, A FULL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO DEVIATIONS, REWORK ACTIVITIES, OR MAINTENANCE EVENTS ASSOCIATED WITH THE MALFUNCTION WERE IDENTIFIED. NO VISUAL EVIDENCE WAS AVAILABLE TO SUPPORT CONFIRMATION OF THE REPORTED ISSUE. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THE EXPANDED INVESTIGATION INCLUDING UPDATED EQMS SEARCHES AND THE DHR REVIEW NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS).
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT AT SITE ON (B)(6) 2023. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766777 | CONTACT DETACH | UNO CONTACT DETACH G29 80/6 SC1 MIMX | FPA | UNOMEDICAL DEVICES S.A. DE C.V | MMT-866A | 6000933 | 05705244019348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |