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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/9 GREY
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T:90¿ INFUSION SET; INSET II 60/9 GREY 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.The patient reported that the infusion set's cannula was bent.Reportedly, she had high blood glucose level of 600 mg/dl and diabetic ketoacidosis which led to a minor heart attack and subsequently hospitalization.Prior to hospitalization, she self-treated with a bolus.It was stated that the bent cannula was noticed when she removed site for observation while at hospital.During hospitalization, she received insulin drip as corrective treatment which resolved the issue.It was noticed that minimal tissue death in heart had occurred due to minor heart attack and no other permanent damage was seen.The infusion set was used for less than 24 hours.She was hospitalized for three 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.
 
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Brand Name
T:90¿ INFUSION SET
Common Device Name
INSET II 60/9 GREY
MDR Report Key8543065
Report Number3003442380-2019-01356
Device Sequence Number11370441
Product Code FPA
UDI-Device Identifier05705244004450
UDI-Public05705244004450
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 NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2017
Initial Report FDA Received Date04/24/2019
Patient Sequence Number1
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