MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG KIT WITH ENFIT CONNECTOR; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number 50-6020E2

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot 80400743 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.Avanos medical inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported that the patient's replacement tube was checked on (b)(6) 2021 by gastroenterologist in digestive endoscopy.On (b)(6) 2021, the patient had blood reflux in the tube and visualization of tube migration under scanner.

• Brand Name: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Type of Device: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12322146
• MDR Text Key: 266659707
• Report Number: 3006646024-2021-00016
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770469270
• UDI-Public: 00350770469270
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 50-6020E2
• Device Catalogue Number: N/A
• Device Lot Number: 80400743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 39