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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET; KNT TUBES, GASTROINTESTINAL
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ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET; KNT TUBES, GASTROINTESTINAL Back to Search Results
Catalog Number GJS-1400-SHETTY
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/26/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
The peel-away sheath that came with the set was noted to be cracked.They used a different introducer peel-away and completed the procedure with the remainder of the initial set.
 
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Brand Name
ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET
Common Device Name
KNT TUBES, GASTROINTESTINAL
MDR Report Key7273016
Report Number1820334-2018-00514
Device Sequence Number143556
Product Code KNT
UDI-Device Identifier00827002072763
UDI-Public(01)00827002072763(17)180126(10)5525116
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/15/2018
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 Catalogue NumberGJS-1400-SHETTY
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2018
Initial Report FDA Received Date02/15/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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