MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number 98434

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 30166109, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Root cause could not be determined.All information reasonably known as of 26-aug-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).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.

Event Description

It was reported that one safety-pexy broke on the day of placement, (b)(6) 2022, and the other two remained.The next day, an x-ray was performed to verify placement and found that the remaining two safety-pexies were not present.X-ray visualized one t-bar floating in the stomach.The physician was going to send the patient for a bowel wash.The patient is hospitalized and fed via a nasogastric tube.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR 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: 15307473
• MDR Text Key: 305509405
• Report Number: 9611594-2022-00112
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984346
• UDI-Public: 00350770984346
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: 98434
• Device Catalogue Number: N/A
• Device Lot Number: 30166109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female