MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/6 PCC MIMX

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in hong kong.On 27-jan-2024, the patient's parent reported that their child's infusion set needle had broken off while the implant was in the abdomen.There was no needle when infusion set was removed, but the implant site felt itchy and hard bulge was seen under the skin.Moreover, the infusion set had been used for 3 days.Therefore, the parents took the child for computed tomography (ct) scan and on 24-jan-2024 at 23:17 pm, the test results confirmed that the broken needle was under the skin.Moreover, the child's blood glucose level was 20 mmol/l and insulin pump were used to control blood glucose level.Further, on 25-jan-2024 at noon, it was informed that the needle was surgically removed in the hospital.No further information was available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 60/6 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18634243
• MDR Text Key: 334493644
• Report Number: 3003442380-2024-00136
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2024

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?: No
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/28/2024
• Initial Date FDA Received: 02/02/2024
• Patient Sequence Number: 1