MAUDE Adverse Event Report: AVANOS MEDICAL INC. 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 No Code Available (3191)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Could not swallow, shortness of breath.The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 13-nov-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 halyard health 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 halyard health.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 Description

Fill volume: 550 ml.Flow rate: 8 ml/hr.Procedure: shoulder surgery.Cathplace: innerscalene.Date of surgery: (b)(6) 2020.It was reported the "patient was discharged at 430pm on the (b)(6) and could not talk and was having trouble swallowing at that time.Nurses did not think anything of patient not being able to talk and stated that it could be from the block.Was home by 530[pm] and could not swallow and over the next hour felt like throat was closing on him.Called surgeon who had him remove the pump.Patient fully recovered within 3-4 hours of pump being removed." the patient had shoulder surgery on the (b)(6).The pump had medication remaining in it once it was removed.

Manufacturer Narrative

Correction (d4-lot number): 30049135.One sample device was returned and the device was evaluated.The evaluation summary concluded the pump's distal end infused when selected rates were checked during infusion verification.When pressure pot testing was performed and all tested rates met specifications.The device history record for the reported lot number,30049135, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.A root cause was not identified.All information reasonably known as of 13-jan-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 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.

• 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 INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10862612
• MDR Text Key: 218682057
• Report Number: 2026095-2020-00127
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2022
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30049135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/14/2021
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE 0.2%
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 128