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

Model Number 98433

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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 13-jul-2022 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 (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused.

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 9611594-2022-00097 for the second event.Refer to 9611594-2022-00098 for the third event.It was reported the "t-pexy/t-fasteners seem too tight(sutures seem too short- retracted in button per interventional radiology provider), staying in >4-6 weeks (not falling out on their own- often 1 button falls off but the other button remain connected)," infection at the site.

Manufacturer Narrative

The device history record for the reported lot number, 30178016, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 26-aug-2022 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 (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
• Type of Device: DH 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 Key: 15009182
• MDR Text Key: 295855014
• Report Number: 9611594-2022-00093
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984339
• UDI-Public: 00350770984339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: 98433
• Device Catalogue Number: N/A
• Device Lot Number: 30178016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG