MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-431AH

Device Problems Difficult to Insert (1316); Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/26/2023

Event Type  Injury  

Event Description

The extended infusion set from medtronic/minimed did not fully insert when the button was "fired".All directions were followed and i used it as i have normally used it/same manner since beginning use.The device/insert portion was faulty and seemed that the needle portion was bent.It caused a lot of bleeding and was not useable.

• Brand Name: MEDTRONIC EXTENDED INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 17127835
• MDR Text Key: 317229882
• Report Number: MW5118381
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2024
• Device Model Number: MMT-431AH
• Device Lot Number: 5390530
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: INSULIN PUMP, NOVOLOG INSULIN, TRUVADA.; VITAMIN D3, PROBIOTICS, FIBER.
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White