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 Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported while in interventional radiology "the sutures broke/came away as the gastrostomy tube was being placed, the tube ended up between the abdominal wall and the stomach." a nasogastric tube was inserted.The patient was receiving total parenteral nutrition (tpn) and was to remain in the "nothing by mouth" (nbm) status.The patient was stable with no signs and symptoms of peritonitis.There was no reported injury.The clinicians noted a re-attempt of the radiologically inserted percutaneous gastrostomy (rig) procedure was to be on (b)(6) 2022 but no additional information has been received on the status of that procedure.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 20048909, 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 31-mar-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, 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: 13981035
• MDR Text Key: 289616565
• Report Number: 9611594-2022-00035
• 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,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98431
• Device Catalogue Number: N/A
• Device Lot Number: 20048909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1