CONTACT DETACH
Report
- Report Number
- 3003442380-2026-00216
- Event Type
- Injury
- Date Received
- January 30, 2026
- Date of Event
- December 17, 2025
- Report Date
- March 21, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244025288
- PMA / PMN Number
- K041545
- 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 MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN JUST A PHOTO WAS PROVIDED. THE EVIDENCE IN THE PHOTO IS INSUFFICIENT TO OBJECTIVELY CONFIRM THE CLAIM REGARDING ADHESIVE ISSUE, MORE INFORMATION WAS REQUESTED TO THE CUSTOMER SINCE THE CONDITION OF THE MATERIAL CANNOT BE PROPERLY EVALUATED BASED SOLELY ON AN IMAGE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED, THE REPORTED ISSUE CANNOT BE CONFIRMED WITHOUT A PHYSICAL SAMPLE FOR DETAILED ANALYSIS.
THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2026-00216), WAS SUBMITTED ON 30-JAN-2026. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 06-FEB-2024. 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 6013575 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS, ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO), THE REVIEW CONFIRMED THAT LOT 6013575 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 05-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013575 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE, REFER TO), THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013575 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MACHINE M14 ON 06-FEB-2024 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 FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE ADHESIVE PATCH COMPLETELY DETACHES DURING USE- DETACHMENT / SIGNIFICANT WETNESS. 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. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN JUST A PHOTO WAS PROVIDED. CONCLUSION: VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE UNAVAILABILITY OF A RETURNED PHYSICAL SAMPLE. THE CUSTOMER ONLY PROVIDED A PHOTOGRAPH SHOWING SIX USED CANNULAS. HOWEVER, THE EVIDENCE IN THE PHOTO IS INSUFFICIENT TO OBJECTIVELY CONFIRM THE CLAIM REGARDING ADHESIVE ISSUE, SINCE THE CONDITION OF THE MATERIAL CANNOT BE PROPERLY EVALUATED BASED SOLELY ON AN IMAGE, THE REPORTED ISSUE CANNOT BE CONFIRMED WITHOUT A PHYSICAL SAMPLE FOR DETAILED ANALYSIS. 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). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 6013575 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 THE SAMPLE IS NOT AVAILABLE FOR RETURN JUST A PHOTO WAS PROVIDED. THE EVIDENCE IN THE PHOTO IS INSUFFICIENT TO OBJECTIVELY CONFIRM THE CLAIM REGARDING ADHESIVE ISSUE, SINCE THE CONDITION OF THE MATERIAL CANNOT BE PROPERLY EVALUATED BASED SOLELY ON AN IMAGE, THE REPORTED ISSUE CANNOT BE CONFIRMED WITHOUT A PHYSICAL SAMPLE FOR DETAILED ANALYSIS.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SITE FELL OFF ISSUE ON (B)(6) 2025. THERE WERE 6 INFUSION SETS BUT PATIENT FACED INFECTION AND RED MARK FROM ONE INFUSION SET. THE PATIENT USED ANTIBIOTIC CREAM AND ORAL MEDICINES TO TREAT INFECTION. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113265 | CONTACT DETACH | UNO CONTACT DETACH G29 60/6 BETA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | FG000016-03 | 6013575 | 05705244025288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male |