MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number	CB6004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is in-progress.All information reasonably known as of 28-jan-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 750 ml.Flow rate: 10ml/hr.Procedure: full knee replacement.Cathplace: knee area.Date of procedure: (b)(6) 2021.It was reported the "patient had a few drips of medication on the skin during removal and now has second degree burns on his thigh" and blistering was noted on the thigh.Additionally, the patient reported experiencing pain.
Additional Manufacturer Narrative
The device history record for the reported lot number, 20035667, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Photographs of the device was provided.The photographs were reviewed and showed that a reaction was observed in the customer's skin.Based on the use review, potentially, patient believes that it's from the local that hit his skin after he removed.A root cause was not identified.All information reasonably known as of (b)(6) 2021 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 (b)(6) 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 (b)(6).(b)(6) 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 halyard health 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 a (b)(6) product is defective or caused serious injury.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11252148
• Report Number: 2026095-2021-00033
• Device Sequence Number: 3563531
• Product Code: MEB
• UDI-Device Identifier: 00193494134761
• UDI-Public: 00193494134761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/26/2023
• Device Model Number: CB6004
• Device Catalogue Number: N/A
• Device Lot Number: 20035667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2%ROPIVICAINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 79