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
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 550 ml.Flow rate: 6 ml/hr.Procedure: hand procedure supraclavicular.Block performed.Cathplace: unknown.Date and time of the start: 12pm on (b)(6) 2021.Date and time of finish: on the morning of (b)(6) 2021.The pump was clamped and removed.It was reported the patient "indicated that the medication ran out much too quickly during her treatment." there was no reported injury.Additional information received 22-oct-2021 stated the patient experienced "nausea".Surgeon saw patient recently for a post-operative visit and the patient is currently "doing fine".No other details provided.
Additional Manufacturer Narrative
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 04-nov-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.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).
Additional Manufacturer Narrative
The device history record for the reported lot number, 80401040, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample was received with a catheter wrapped in a tegaderm patch.The catheter was extracted from the sample device.The pump was received partially filled, with the pinch clamp closed.The fill port cap was attached.There was no cap on the distal luer.There was no obvious damage to the pump.The pump was evaluated for flow rate and the flow evaluation was within specification.The catheter was examined and it was noted as non-avanos medical product.The item was photographed for documentation, but functional evaluation was not performed.Root cause could not be determined.All information reasonably known as of 14-dec-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
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12759264
• Report Number: 2026095-2021-00102
• Device Sequence Number: 3170646
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 80401040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2% ROPIVACAINE; NON-AVANOS CATHETER
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 56 KG