MAUDE Adverse Event Report: MIO; INSET II 80/6 PCC PINK

Model Number MMT-925

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, the parent of the patient reported that as their daughter woke up this morning, it was noticed that the infusion set's tubing was disconnected from the clip at the quick release, while she was sleeping.Reportedly, the tubing was still connected to the pump and the end looked like a big ball of glue.The site location was her stomach and the pump was probably in pants or shorts.The infusion set was used for a day and they were stored in a plastic shelf container.They were unsure of any stress or pull on the tubing, but the pump was not dropped with the set connected to her body.No further information available.

• Brand Name: MIO
• Type of Device: INSET II 80/6 PCC PINK
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 10447234
• MDR Text Key: 204228003
• Report Number: 3003442380-2020-00365
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007871
• UDI-Public: 05705244007871
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2023
• Device Model Number: MMT-925
• Device Lot Number: 5311063
• Date Manufacturer Received: 08/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1