Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MIO¿; INSET II 60/6 PCC PINK Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that, on (b)(6) 2016, the daughter found the patient unconscious and called the paramedics.Therefore, on the same day at 01:00 pm, the patient was admitted in the hospital by the paramedics for diabetic ketoacidosis and blood glucose level of 1300 mg/dl.When the infusion set was removed it was found that the cannula was bent.Previously, she changed her infusion on (b)(6) 2016 and it had been in use for three days.Reportedly, the site location was her abdomen.During hospitalization, she received intravenous drip with saline, insulin shots and potassium pills.The patient was hospitalized for four days.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MIO¿
Common Device Name
INSET II 60/6 PCC PINK
MDR Report Key9478941
Report Number3003442380-2019-01976
Device Sequence Number14337939
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? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/17/2019
Patient Sequence Number1
-
-