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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC PINK
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MIO¿; INSET II 46/6 PCC PINK Back to Search Results
Lot Number 5163245
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 the infusion set broke.Reportedly, while the patient opened it and took the tubing out, it came off and the patient was not able to reattach it.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 46/6 PCC PINK
MDR Report Key8459342
Report Number3003442380-2019-00784
Device Sequence Number344576
Product Code FPA
UDI-Device Identifier05705244007376
UDI-Public05705244007376
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 Number5163245
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2016
Initial Report FDA Received Date03/28/2019
Patient Sequence Number1
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