MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE; DH EF BALLOON TUBES PRODUCTS

Model Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Fever (1858)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 18 aug 2020 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 inc.Complaint database and identified as complaint (b)(4).

Event Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 9611594-2020-00156 for the first report.It was reported that the "balloon was inflated with air, not using distilled water.After that nutrition was injected while the distal end of the tube was in the abdominal cavity.Nutrition came into the abdominal cavity." the user has admitted that their procedure was incorrect.Additional information received 04-aug-2020 indicated the patient had a fever and abdominal pain the day following the event.The patient's current health status is "recovered." additional information received 05-aug-2020 indicated the device is from the "0620" product family, but the exact model number is unknown.

• Brand Name: UNKNOWN MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE
• 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: 10424863
• MDR Text Key: 221305067
• Report Number: 9611594-2020-00157
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• 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 Age: 71 YR