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  

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.All information reasonably known as of 22 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 complaint database and identified as complaint (b)(4).

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 second of four reports.Refer to 9611594-2022-00047 for the first report.Refer to 9611594-2022-00049 for the third report.Refer to 9611594-2022-00050 for the fourth report.It was reported that the buttons had come off within a day or two of placement during rig (radiologically inserted percutaneous gastrostomy) insertion.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.".

• 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: 14207661
• MDR Text Key: 290151718
• Report Number: 9611594-2022-00048
• 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

• Date FDA Received: 04/26/2022
• 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
• Date Manufacturer Received: 04/05/2022
• 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