MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number 98431

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the third of four reports.Refer to (b)(4) for the first report.Refer to (b)(4) for the second report.Refer to (b)(4) for the fourth report.It was reported that "last week we had a patient who had to convert to surgical peg placement as 3 gastropexy sutures broke and lost adherence of stomach to abdomen wall.The radiologist did say he thought it was a technical problem due to anatomy and a very difficult placement.Per additional information received 11 apr 2022, "before the procedure we clean the skin with skin disinfectant licensed medicines 2% chlorhexidine gluconate in 70% ipa sterile 3ml applicator, and only sterile water/gauze is used afterwards before a mepore dressing applied".

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.The device history record for lot 30144446 was reviewed and the product was produced according to product specifications.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).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 serious injury.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR 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: 14207670
• MDR Text Key: 290089944
• Report Number: 9611594-2022-00049
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984315
• UDI-Public: 00350770984315
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: 98431
• Device Catalogue Number: N/A
• Device Lot Number: 30144446
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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