MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC BLUE

Lot Number	5198662
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 (b)(6).The patient reported that the last infusion set from the box was defective as the tubing was detached from the site that was sticking onto the body.Upon investigation, it was found that the tubing was detached from the tubing connector and excess of glue was noticed where tubing was joined on the tubing connector.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 8511997
• Report Number: 3003442380-2019-01115
• Device Sequence Number: 16584798
• Product Code: FPA
• UDI-Device Identifier: 05705244007512
• UDI-Public: 05705244007512
• 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: 06/01/2020
• Device Lot Number: 5198662
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2018
• Initial Report FDA Received Date: 04/13/2019
• Patient Sequence Number: 1