CONTACT DETACH
Report
- Report Number
- 3003442380-2025-15638
- Event Type
- Malfunction
- Date Received
- November 3, 2025
- Date of Event
- October 5, 2025
- Report Date
- November 5, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244018488
- PMA / PMN Number
- K041545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-15638), WAS SUBMITTED ON 03-NOV-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 25-MAR-2025. 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 6012374 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012374 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 25/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5C04485 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 24/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5C01396 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 WELDING IN THE MACHINE LS06 & LS07, ON 25/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING THE LOT 5B03016 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 04/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5B04501 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 23/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5B02915 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 25/MAR/202, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5C05029 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 39 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 25/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR THE LOT 5B04502 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 38 IN THE GLUING OF CONNECTOR IN THE LINE 03, ON 03/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 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 COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
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. THE BLOCKAGE WAS AT THE SITE. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1076854 | CONTACT DETACH | UNO CONTACT DETACH G29 60/8TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 1002835 | 6012374 | 05705244018488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male |