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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC BLUE
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MIO¿; INSET II 80/6 PCC BLUE Back to Search Results
Lot Number 5272022
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 (b)(6).The patient reported that the infusion set's tubing got loose and came apart from the cannula part during the night.The patient was unsure if there was stress or pull on the tubing and the pump was not dropped with the set in place.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 80/6 PCC BLUE
MDR Report Key8863681
Report Number3003442380-2019-01691
Device Sequence Number2196314
Product Code FPA
UDI-Device Identifier05705244007734
UDI-Public05705244007734
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 Date02/01/2022
Device Lot Number5272022
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/24/2019
Initial Report FDA Received Date08/06/2019
Patient Sequence Number1
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