MAUDE Adverse Event Report: AVANOS UNKNOWN MICROCUFF; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number UNKNOWN

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 14dec2021 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 (b)(4).

Event Description

Avanos medical inc.Received a single report that referenced 2 (two) different incidences, which were associated with separate units, involving 2 (two) different patients.This is the first of two reports.Refer to 9611594-2021-00186 for the second report.The customer reported that the cuff on the microcuff deflated.There was no reported injury and additional information has been requested.

• Brand Name: UNKNOWN MICROCUFF
• Type of Device: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS; 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: 13010127
• MDR Text Key: 283977907
• Report Number: 9611594-2021-00185
• Device Sequence Number: 1
• Product Code: BRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2021
• 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
• Patient Sequence Number: 1