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

Model Number 98430

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2022

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 11 may 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that the physician performed an introducer placement kit (ipk) to mickey-g procedure; it was endoscopically monitored. After the serial dilator was removed and the tube was placed the physician noted, while removing the guidewire, that a small white plastic piece was stuck on the guidewire at the base of the g-tube; it was the tip of the dilator, which had snapped off inside of the patient. The physician stated that it was small enough to pass through [the patient¿s intestines]. There was no reported injury to the patient. No additional information was provided concerning the passing of the tip of the dilator.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
• 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: 14402516
• Report Number: 9611594-2022-00061
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984308
• UDI-Public: 00350770984308
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/19/2023
• Device Model Number: 98430
• Device Catalogue Number: N/A
• Device Lot Number: 30136727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: KG