MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC BLUE

Lot Number	5248531
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that infusion set's tubing came straight out of the quick release while the patient was sleeping, doing nothing out of ordinary routine.This issue occurred three times and recently, last week on (b)(6) 2019, the same issue occurred two times.The site location was at patient's buttock and the pump was hooked on his side, to his pants.The infusion had been in use for only a day and a half.Reportedly, the infusions were stored inside of a cabinet in the house.The patient was unsure if there was any stress or pull on the tubing and the pump was not dropped with the set connected to his body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 8959099
• Report Number: 3003442380-2019-01784
• Device Sequence Number: 2859715
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/01/2021
• Device Lot Number: 5248531
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/04/2019
• Patient Sequence Number: 1