MAUDE Adverse Event Report: MIO ADVANCE; MIO ADVANCE GREY 60/6 PCC

Model Number MMT-242

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that infusion set's tubing came apart as it was pulled out accidentally on the first day of usage.On (b)(6) 2020, it was inserted in patient's upper arm.Moreover, on (b)(6) 2020, they received an alert.Reportedly, there was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

Event Description

On 04-feb-2021: follow up information was submitted to update health effect impact code and visual inspection and test for static pull were performed on the returned unused device (10 sets), it was found that all test results were within specifications.Based on the result: medical device problem code and component code have been updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that infusion set's tubing came apart as it was pulled out accidentally on the first day of usage.On (b)(6) 2020, it was inserted in patient's upper arm.Moreover, on (b)(6) 2020, they received an alert.Reportedly, there was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO ADVANCE
• Type of Device: MIO ADVANCE GREY 60/6 PCC
• MDR Report Key: 10909881
• MDR Text Key: 218735935
• Report Number: 8021545-2020-00152
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016323
• UDI-Public: 05705244016323
• Combination Product (y/n): Y
• PMA/PMN Number: K173879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2023
• Device Model Number: MMT-242
• Device Lot Number: 5319804
• Date Manufacturer Received: 11/17/2020
• Patient Sequence Number: 1