MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q C-BLOC INTL PAIN RELIEF SYSTEM W/SELECT-A-FLOW AND ONDEMAND, 400 X 2-14ML/H; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30085020 was reviewed and the product was produced according to product specifications.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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported by the anesthesiologist that the infusion was supposed to be over four days but had completed in 24 hours.The patient reported that he did not use the bolus.There was no injury.
Additional Manufacturer Narrative
Correction: per review it was determined that this complaint is a duplicate of avanos ref(b)(4), reported under medwatch mfr# 2026095-2021-00112.Please see 2026095-2021-00112 for all further follow ups regarding this event.No further reporting will be submitted under 2026095-2021-00113.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.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 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 W/SELECT-A-FLOW AND ONDEMAND, 400 X 2-14ML/H
• 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: 13010081
• Report Number: 2026095-2021-00113
• Device Sequence Number: 13907559
• Product Code: MEB
• UDI-Device Identifier: 00193494134839
• UDI-Public: 00193494134839
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: 08/12/2022
• Device Model Number: CBI006
• Device Catalogue Number: N/A
• Device Lot Number: 30085020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 12/22/2021
• 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