MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number 0120-12-1.7

Device Problem Pressure Problem (3012)

Patient Problem Cellulitis (1768)

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 27-dec-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.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).The device was not returned.

Event Description

Avanos medical, inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different events.This is the third of five reports.Refer to 9611594-2019-00269 for the first event.Refer to 9611594-2019-00270 for the second event.Refer to 9611594-2019-00272 for the fourth event.Refer to 9611594-2019-00273 for the fifth event.It was reported the patient experienced skin breakdown and pressure under the newly placed mic-key gastrostomy tube.The surgeons placing the device are disagreeing with the wound ostomy team that these are pressure related injuries.However, the wound ostomy care nurse (wocn) team is staging it as a pressure injury (cellulitis).

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 12 FR, 1.7 CM
• 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: 9528452
• MDR Text Key: 175104043
• Report Number: 9611594-2019-00271
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770948317
• UDI-Public: 00350770948317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0120-12-1.7
• Device Catalogue Number: 109483102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention