MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND NRFI CONNECTOR; ELASTOMERIC - SAF

Model Number CB004-N

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tinnitus (2103); No Code Available (3191)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 17-feb-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

Fill volume: unknown.Flow rate: 4ml/hr to 6 ml/hr.Procedure: shoulder surgery.Cathplace: unknown.It was reported during use the patient stated, "ringing in the ears the day after surgery.Anesthesia has called him to follow up the day after surgery and he told him about the ringing and the metal taste in the mouth and facial drooping." anesthesia instructed the patient the symptom should go away.Additionally, the "patient has seen an audiologist, a neurologist and his primary care doctor.All tests have been normal and they can not find a problem however the patient states that he has ringing in the ears to the point where he has to take klonopin to sleep." the clinicians prescribed intriptyline and valium and neither of the medications helped the patient.The patient was unsure about the drug that was placed in the pump but he does remember that it was running at 4ml/hr after coming home from the hospital, and he turned it up to 6ml/hr that first night because he was in pain.No additional information was provided.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND NRFI CONNECTOR
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9721875
• MDR Text Key: 188342306
• Report Number: 2026095-2020-00027
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: CB004-N
• Device Catalogue Number: 104493001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/18/2020
• 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
• Patient Age: 57 YR
• Patient Weight: 82