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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC BLUE
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MIO¿; INSET II 46/6 PCC BLUE Back to Search Results
Lot Number 5152541
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's father reported that the tubing came loose at the infusion set.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 46/6 PCC BLUE
MDR Report Key8463035
Report Number3003442380-2019-00811
Device Sequence Number16502945
Product Code FPA
UDI-Device Identifier05705244007314
UDI-Public05705244007314
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 Date09/01/2019
Device Lot Number5152541
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/17/2017
Initial Report FDA Received Date03/29/2019
Patient Sequence Number1
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