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: T:90¿ INFUSION SET; INSET II 60/6 GREY
  • 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
 

T:90¿ INFUSION SET; INSET II 60/6 GREY Back to Search Results
Lot Number 5167092
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 the patient faced bent cannula issue due to which he experienced high blood glucose level reported to be over 500 mg/dl.His supplies were changed out, and he was given a bolus.He also had kidney issues and a heart attack.Subsequently, he was admitted to the hospital where he received insulin via intravenous drip, heart operation to insert a stent and possible dialysis, which resolved the issue.The patient was about to be released when he accidentally injected some insulin from a 300-unit tandem syringe directly into his body.Therefore, he remained in the hospital as they were unsure how much insulin he received.The patient stayed in the hospital for ten 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
T:90¿ INFUSION SET
Common Device Name
INSET II 60/6 GREY
MDR Report Key8538502
Report Number3003442380-2019-01374
Device Sequence Number361127
Product Code FPA
UDI-Device Identifier05705244004412
UDI-Public05705244004412
Combination Product (Y/N)N
PMA/510(K) Number
K032854
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 Number5167092
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2017
Initial Report FDA Received Date04/23/2019
Patient Sequence Number1
-
-