CONTACT DETACH
Report
- Report Number
- 3003442380-2025-17188
- Event Type
- Injury
- Date Received
- December 8, 2025
- Date of Event
- November 22, 2025
- Report Date
- February 6, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244005693
- PMA / PMN Number
- K041545
- 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 COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4. 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 06-FEB-2026 AGAINST "LOT NUMBER 6013713 AND SIMILAR MALFUNCTION CODES: OCCLUSION ISSUES-CANNOT BE DETERMINED, OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED. THE REVIEW CONFIRMED THAT LOT 6013713 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 06-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013713 AND SIMILAR MALFUNCTION CODES OCCLUSION ISSUES-CANNOT BE DETERMINED, OCCLUSION (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED). IF THERE IS NO TROUBLESHOOTING, INCONCLUSIVE TROUBLESHOOTING, OR PARTIAL TROUBLESHOOT DONE AND IT CANNOT BE CONCLUDED TO BE INFUSION RELATED, REFER TO CANNOT BE DETERMINED CANNOT BE DETERMINED. NO ESCALATION REQUIRED. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013713 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MULTIVAC M14 ON 08-JUN-2025 WITH A TOTAL OF (B)(4) UNITS. THE WELDING, OF THE LOT 5E04021 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE GLUING MACHINE LS24 - LS25, ON 07-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING, OF THE LOT 5E04017 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE GLUING MACHINE LS06 - LS07, ON 06-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING, OF THE LOT 5E06047 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE GLUING MACHINE LS24 - LS25, ON 04-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING, OF THE LOT 5E04007 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE GLUING MACHINE LS06 - LS07, ON 02-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE WELDING, OF THE LOT 5E03376 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE GLUING MACHINE LS11, ON 01-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02179 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 07-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02180 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02182 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 08-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02175 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 06-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02176 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 06-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02173 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 04-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E03991 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 05-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02174 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 05-JUN-20245, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02170 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 02-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02171 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 03-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02172 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 03-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02173 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 04-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5E02165 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 29-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5F02586 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 14-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING CONNECTOR, OF THE LOT 5F03092 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE GLUING MACHINE 03, ON 15-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 5E03914 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE GLUING MACHINE SC08, ON 30-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 5E03909 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE GLUING MACHINE SC05 - SC06, ON 30-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 5E03912 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE GLUING MACHINE SC08, ON 26-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. 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 OCCLUSION ISSUES-CANNOT BE DETERMINED ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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 6013713 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.
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 INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025 WHICH LED TO HIGH BLOOD GLUCOSE LEVEL AND THE PATIENT FELT DISORIENTED. THE BLOOD GLUCOSE VALUE PEAKED AT 400MG/DL. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143268 | CONTACT DETACH | UNO CONTACT DETACH G29 60/6 MIMX | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-863 | 6013713 | 05705244005693 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female |