MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q C-BLOC INTL PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND ONDEMAND, 400 X 2; ELASTOMERIC - COMBO

Model Number	CBI006
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown.It was reported the device was to infuse in 4-days, however the device infused in 24-hours.There was no reported patient injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30085020, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.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 15-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.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
According to the description the pump was empty after-24 hours instead of 4-days, the customer believes that the bolus lock of the pump broke and the bolus had a continuous flow of 5mlx30min.The flow rate of a pump could be affected by different external factors such as filling the pump less than the labeled fill volume and the increase of temperature, the filling volume of the pump was not provided and no additional information about the user and facility conditions were provided; therefore, it was not possible to know if this could have contributed to the failure.Additional to this, per instructions for use (ifu) the labeled flow rates are based on the use of normal saline as a diluent.If a different diluent/drug is used the viscosity could be affected and cause the flow rate to increase.Regarding the possible breakage at the bolus site, no pictures were provided and it was not possible to determine if the bolus was working properly, if the red tab was not removed the flow would be continuous which could cause the fast flow.Root cause could not be determined.All information reasonably known as of 13-jan-2022 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 C-BLOC INTL PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND ONDEMAND, 400 X 2
• Common Device Name: ELASTOMERIC - COMBO
• 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: 13021331
• Report Number: 2026095-2021-00112
• Device Sequence Number: 5188937
• Product Code: MEB
• UDI-Device Identifier: 00193494134839
• UDI-Public: 00193494134839
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: 08/12/2022
• Device Model Number: CBI006
• Device Catalogue Number: N/A
• Device Lot Number: 30085020
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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: Male