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	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Dyspnea (1816); Anxiety (2328); Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for lot 20035683 was reviewed and the product was produced according to product specifications.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 07 may 2021 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 complaint (b)(4).Device not returned.
Event or Problem Description
Fill volume: unknown.Flow rate: 6ml/hr, 14ml/hr.Procedure: wrist surgery.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the patient was feeling anxious and noticed shortness of breath [sob] and did not feel well when the pump was set to 14ml/hr for "3-4 hours." pump was set to 6ml/hr but turned up to 14ml/hr to help with pain.Patient did not feel well on the start of day two and felt the pump when from a softball size to a baseball size in a matter of two hours.Patient stated that he did not receive any relief from pain.Patient recovered after pump was removed.Additional information received 20-apr-2021 indicated the surgery occurred on (b)(6) 2021.Patient is still in pain and is having shoulder pain since removal of the pump.Additional information has been requested but not yet received.

• 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: 11793031
• Report Number: 2026095-2021-00056
• Device Sequence Number: 4017601
• Product Code: MEB
• UDI-Device Identifier: 00193494134761
• UDI-Public: 00193494134761
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 02/03/2023
• Device Model Number: CB6004
• Device Catalogue Number: N/A
• Device Lot Number: 20035683
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Weight: 101