MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS

Model Number 98432

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

Patient Problem Unspecified Infection (1930)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported " the patient had a gastrostomy tube placed on (b)(6) 2021. On (b)(6) 2022, the patient had an emergency consultation for abdominal pain, an inflammatory placard with pus discharge at the gastrostomy orifice. During the care, removal of one of the anchors through the stoma orifice. An abdomino-pelvic scanner was performed, but no subcutaneous abscess was found. The biological work-up did not reveal any inflammatory syndrome. According to the doctor who placed the probe, one of the anchors could have been positioned outside the stomach during the placement. The anchor was visible in the abdominal wall during a computed tomography (ct). Medical treatment in place: initiation of antibiotherapy (pristinamycin) for 8-days to manage the infection. The gastrostomy remained functional.

Manufacturer Narrative

The device history record for the reported lot number, 30129217,in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. The actual complaint product was not returned for evaluation. All information reasonably known as of 21-apr-2022 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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).

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14215497
• MDR Text Key: 290152299
• Report Number: 9611594-2022-00046
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 98432
• Device Catalogue Number: N/A
• Device Lot Number: 30129217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/26/2022 Patient Sequence Number: 1