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

Lot Number	5217374
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
(b)(4).Event occurred in the united states.The patient stated that the tubing got detached from the body and site location was lower abdomen.The location of detachment was quick release.She was unsure whether the pump was located on the counter or attached to her pants.She was not able to use the infusion as the issue occurred right away.Infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump wasn't dropped with the set connected to the body.No further information available.
Event or Problem Description
On 16-oct-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set), showed that the tubing was detached from the tubing connector (missing glue).Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that on (b)(6) 2018, the infusion set's tubing got detached from the body and site location was lower abdomen.The location of detachment was quick release.She was unsure whether the pump was located on the counter or attached to her pants.She was not able to use the infusion as the issue occurred right away.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump wasn't dropped with the set connected to the body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC BLUE
• MDR Report Key: 8211615
• Report Number: 3003442380-2019-00102
• Device Sequence Number: 11269042
• Product Code: FPA
• UDI-Device Identifier: 05705244007734
• UDI-Public: 05705244007734
• 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,Followup

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: 12/01/2020
• Device Lot Number: 5217374
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1