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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK
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MIO¿; INSET II 60/6 PCC PINK Back to Search Results
Lot Number 5244158
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 (b)(6).The patient reported that the infusion set's tubing detached.Moreover, the patient checks the tubing prior to insertion.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 60/6 PCC PINK
MDR Report Key9127376
Report Number3003442380-2019-01821
Device Sequence Number2503274
Product Code FPA
UDI-Device Identifier05705244007697
UDI-Public05705244007697
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 Date07/01/2021
Device Lot Number5244158
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2019
Initial Report FDA Received Date09/27/2019
Patient Sequence Number1
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