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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿II; INSET II 60/9 GREY
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INSET¿II; INSET II 60/9 GREY Back to Search Results
Lot Number 5183265
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 (b)(6).The patient had tubing issues, the tubes were cracked/broken.Two sets had tubing snap off the connection needle, first on day 1, second on day 2.No further information available.
 
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Brand Name
INSET¿II
Common Device Name
INSET II 60/9 GREY
MDR Report Key8280308
Report Number3003442380-2019-00224
Device Sequence Number2463169
Product Code FPA
UDI-Device Identifier05705244007574
UDI-Public05705244007574
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 Date04/01/2020
Device Lot Number5183265
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2017
Initial Report FDA Received Date01/27/2019
Patient Sequence Number1
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