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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/6 GREY
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T:90¿ INFUSION SET; INSET II 60/6 GREY Back to Search Results
Lot Number 5114231
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 united states.The patient reported that the infusion set's cannula was bent at the infusion site.Reportedly, the patient's blood glucose was above 600 mg/dl and had experienced diabetic ketoacidosis.The patient self-treated with insulin via injection.Subsequently, the patient went to the emergency room followed with hospitalization where insulin drip and some unspecified intravenous fluids were given which resolved the issue.The patient was hospitalized for two days and there was no permanent damage to the patient.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.
 
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Brand Name
T:90¿ INFUSION SET
Common Device Name
INSET II 60/6 GREY
MDR Report Key8538783
Report Number3003442380-2019-01353
Device Sequence Number2431181
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 Number5114231
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2017
Initial Report FDA Received Date04/23/2019
Patient Sequence Number1
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