MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tinnitus (2103)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device history record for the reported lot number in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.All information reasonably known as of 09-jun-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.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.The device was not returned.

Event Description

Fill volume: unknown.Flow rate: 4ml/hr.Procedure: total knee replacement.Cathplace: unknown.Date of procedure: (b)(6) 2020.It was reported that during use of the device the patient "he has had ringing in his ears from dental surgery years ago but it's back now and much worse.He was told he had an allergy to local from his dentist, but he never told anyone about it from surgery." the device was in use for 4-days.Patient stated the pump still has medication in it and was leaking all over.The patient was advised to clamp the device and dispose of the device.The device was removed and the black tip of the device was intact during removal.The patient was advised to contact anesthesia should his tinnitus get worse or not return to it's baseline.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• 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: 10137811
• MDR Text Key: 240363010
• Report Number: 2026095-2020-00084
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2022
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 20008644
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 82