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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98433
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2020
Event Type  malfunction  
Manufacturer Narrative
The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 08-jan-2021 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical, inc. Represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint comp-(b)(4).
 
Event Description
Avanos medical, inc. Received a single report that referenced three different incidences, which were associated with separate units, involving three different events. This is the first of three reports. Refer to 9611594-2021-00002 for the second event. Refer to 9611594-2021-00003 for the third event. It was reported the sutures on the t-fasteners broke during initial use. There was no reported injury.
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
Type of DeviceDH EF PERC PLACEMENT PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V. (AVENT 1)
circuito industial no.40
colonia obrera
nogales, cp
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key11152688
MDR Text Key252692171
Report Number9611594-2021-00001
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98433
Device Catalogue NumberN/A
Device Lot Number30095899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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