MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 80/10 SC1 MIMX

Model Number MMT-886A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in germany.On (b)(6) 2022, it was reported that the patient's infusion set's needle broke on (b)(6) 2022 during needle removal.Consequently, in the evening of the same day ((b)(6) 2022), the patient went to the hospital, as the needle was stuck in the flank while removing it and it had to be operated out.In the hospital the patient was repeatedly x-rayed in between to see if any part of the needle was still in the skin.The needle could not be removed completely.When a new set was inserted the remaining part of the needle was removed from the body.No further information available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 80/10 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15162101
• MDR Text Key: 297211994
• Report Number: 3003442380-2022-00917
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019461
• UDI-Public: 05705244019461
• Combination Product (y/n): Y
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/01/2023
• Device Model Number: MMT-886A
• Device Lot Number: 5320303
• Date Manufacturer Received: 07/16/2022
• Patient Sequence Number: 1