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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/9 GREY TCAP
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AUTOSOFT 90; INSET II 60/9 GREY TCAP Back to Search Results
Lot Number UNKNOWN
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 the united states.The patient reported that his infusion set tubing (only the patient line) disconnected from the infusion set site.No further information available.
 
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Brand Name
AUTOSOFT 90
Common Device Name
INSET II 60/9 GREY TCAP
MDR Report Key8188532
Report Number3003442380-2018-00118
Device Sequence Number13959796
Product Code FPA
UDI-Device Identifier05705244014367
UDI-Public05705244014367
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? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2018
Initial Report FDA Received Date12/21/2018
Patient Sequence Number1
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