MAUDE Adverse Event Report: MIO; INSET II 80/9 PCC GREY

Model Number	MMT-975
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 reported for defective infusion sets.She stated that this is the only batch that she had encountered issues with.Her sets fell off whenever she woke up in the morning and she had to change her infusion sets for 3 consecutive days because they just fell off for no reason.She was unsure for the cause of the product not adhering.The patient prepared the site by using uses alcohol but used to let it dry first and she does not perspire heavily.Upon investigation of the returned used device (1 tubing), it showed that the tubing was detached from the tubing connector.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 80/9 PCC GREY
• MDR Report Key: 9749112
• Report Number: 3003442380-2020-00184
• Device Sequence Number: 11560488
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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 Model Number: MMT-975
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1