MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. CONTACT DETACH; UNO CONTACT DETACH G29 60/8TCAP 10PK INT

Model Number	1002835
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient had experienced an infusion set tubing blockage and high blood glucose event on (b)(6) 2026.The site location was the abdomen.The blood glucose level was 434 mg/dl.The high blood glucose was resolved by a correction injection via multiple daily dose (mdi).No further information available.
Additional Manufacturer Narrative
Request was performed for additional information including lot number; however, lot number was not provided.A complaint investigation was initiated under complaint investigation.Unfortunately, no specific lot number was identified, which limits the ability to trace or analyze a particular item.Investigation in progress.

• Brand Name: CONTACT DETACH
• Common Device Name: UNO CONTACT DETACH G29 60/8TCAP 10PK INT
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p, 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24740396
• Report Number: 3003442380-2026-06294
• Device Sequence Number: 8859760
• Product Code: FPA
• UDI-Device Identifier: 05705244018488
• UDI-Public: 05705244018488
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1002835
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 89 KG