MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 80/8 SC1 MIMX

Model Number MMT-876A

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 the united states.On (b)(6) 2022, the patient reported that on (b)(6) 2022 (wednesday), when he woke up, his infusion set's needle broke off and it fell off.Therefore, he tried to dig it out but did not find it and on (b)(6) 2022, the patient was admitted to the hospital with blood glucose level of 198 mg/dl for an outpatient procedure to remove the needle and extraction of the foreign body.Moreover, the site location was patient's stomach and the infusion set had been inserted on tuesday (one day before (b)(6) 2022).No further information available.

Event Description

On 14-sep-2022 iv: follow up information was submitted to update the awareness date and the result of complaint investigation of the returned used device (1 set) showed that the steel introducer needle had damages (broken needle) and making it impossible to use the infusion set.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On 29-jul-2022, the patient reported that on 27-jul-2022 (wednesday), when he woke up, his infusion set's needle broke off and it fell off.Therefore, he tried to dig it out but did not find it and on (b)(6) 2022, the patient was admitted to the hospital with blood glucose level of 198 mg/dl for an outpatient procedure to remove the needle and extraction of the foreign body.Moreover, the site location was patient's stomach and the infusion set had been inserted on tuesday (one day before 27-jul-2022).No further information available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 80/8 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15189470
• MDR Text Key: 297496106
• Report Number: 3003442380-2022-00933
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019409
• UDI-Public: 05705244019409
• 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,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-876A
• Device Lot Number: 5362795
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1