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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC PINK
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MIO¿; INSET II 80/6 PCC PINK Back to Search Results
Lot Number 5234899
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 reported that the infusion set tubing had detached during insertion and it fell out of the injector.The site location was patient's left abdomen.The pump was worn when the patient was just trying to insert the infusion set.The infusion had been in use on the first day and the infusions were stored in a closet.There was no stress or pull on the tubing and the pump was not 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 PINK
MDR Report Key8357074
Report Number3003442380-2019-00576
Device Sequence Number11209906
Product Code FPA
UDI-Device Identifier05705244007871
UDI-Public05705244007871
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 Expiration Date04/01/2021
Device Lot Number5234899
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2019
Initial Report FDA Received Date02/21/2019
Patient Sequence Number1
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