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

Model Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Abscess (1690); Pain (1994)

Event Date 04/07/2021

Event Type  Injury  

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.Based on the customer comments and details related to "this is due to a handling error and the operator has not followed the instructions.It was not stated in the medical records that aspiration had been done after the replacement," this event seems to be a non production related incident.All information reasonably known as of 07 may 2021 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).

Event Description

It was reported that the patient came to the hospital acutely on (b)(6) 2021 with stomach pain after switching to the device on (b)(6) 2021.The device was found in the fee abdominal cavity.The patient developed an abscess and was hospitalized with a drain.According to the information received, "this was due to a handling error.The patient is recovering." additional information received 19-apr-2021 indicated "this is due to a handling error and the operator has not followed the instructions.It was not stated in the medical records that aspiration had been done after the replacement (b)(6) 2021.A new feeding tube was inserted and the patient is recovering.Additional information received 20-apr-2021 indicated the patient was discharged from the hospital.Further information is not available.

• Brand Name: UNKNOWN MIC-KEY 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: 11795048
• MDR Text Key: 249971449
• Report Number: 9611594-2021-00069
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: UNKNOWN
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention