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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿II; INSET II 110/6 GREY
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INSET¿II; INSET II 110/6 GREY Back to Search Results
Lot Number 5232844
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
(b)(4).Event occurred in (b)(6).The patient reported tubing came apart from the connector, where it inserts into the housing.Patient stated that needle was still connected to the housing, however, the tubing connected to the needle came apart.No further information available.
 
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Brand Name
INSET¿II
Common Device Name
INSET II 110/6 GREY
MDR Report Key8266302
Report Number3003442380-2019-00227
Device Sequence Number14025406
Product Code FPA
UDI-Device Identifier05705244007918
UDI-Public05705244007918
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 Expiration Date03/01/2021
Device Lot Number5232844
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2018
Initial Report FDA Received Date01/22/2019
Patient Sequence Number1
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