MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR - 14 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 8110-14LV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2019 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.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).Not returned.

Event Description

It was reported that in september a patient had a skin infection around the stoma site.Anti-fungals were used to treat the infection.No further information was provided.Additional information has been requested but not yet received.

• Brand Name: MIC BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR - 14 FR
• Type of Device: DH EF BALLOON TUBES 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: 9320958
• MDR Text Key: 175250988
• Report Number: 9611594-2019-00213
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K842076
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8110-14LV
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention