MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q C-BLOC PAIN RELIEF SYSTM,400 ML,10 ML/HR; ELASTOMERIC LFR

Model Number	CB002
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no information provided regarding the return of the actual complaint product to the manufacturer.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 22-feb-2023 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).This information is submitted pursuant to 21 cfr803, 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.Device not returned.
Event or Problem Description
Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the first of two reports.Refer to 2026095-2023-00016 for the second event.Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported there was a fast flow incident with the pump.There was no injury reported.The customer also reported that it is suspected but not confirmed that the pump "was probably under blankets/warmed during infusion, which may have caused the fast flow." additional information was received on 01-feb-2023 via medwatch/ fda user facility report mw report (b)(4): describe the event or problem: 19600- infused too rapidly- patient noted that on q pumps infused 8 hours prior to expected time that they should have been empty.They were thrown away and not able to send back to clinic.

• Brand Name: ON-Q C-BLOC PAIN RELIEF SYSTM,400 ML,10 ML/HR
• Common Device Name: ELASTOMERIC LFR
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16421706
• Report Number: 2026095-2023-00015
• Device Sequence Number: 14883532
• Product Code: MEB
• UDI-Device Identifier: 00193494134693
• UDI-Public: 00193494134693
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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 Model Number: CB002
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 01/26/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown