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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC GREY
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MIO¿; INSET II 80/6 PCC GREY Back to Search Results
Lot Number 5205771
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 that while the patient changed the infusion set, its tubing detached closed to the quick release/site connector.Reportedly, the tubing disconnected at the site and the tubing came off the clasp while the clasp remained there.The site was on the left side of the waist on the back and then was on the left butt.The infusion was in use for a day, as the infusion set was inserted.It was unsure, whether the infusions were 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.It was unsure whether the pump was dropped with the set connected to the patient's body.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 80/6 PCC GREY
MDR Report Key8490441
Report Number3003442380-2019-01063
Device Sequence Number16584765
Product Code FPA
UDI-Device Identifier05705244007796
UDI-Public05705244007796
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
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 Lot Number5205771
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/29/2018
Initial Report FDA Received Date04/08/2019
Patient Sequence Number1
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