MAUDE Adverse Event Report: AVANOS MEDICAL INC. CB006C HYHSURGPN,400X2-14,CBCMBO,-,OQ,5; ELASTOMERIC - ON-Q WITH BOLUS

Model Number	CB006C
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 550 ml, flow rate: 6ml/hr.Procedure: total knee amputation on (b)(6) 2022.Cathplace: unknown.It was reported the pump "flowed too fast and emptied in less than 24 hours." the device was replaced for a new device.There was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, 30155149, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 24-mar-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.
Additional Manufacturer Narrative
The device was evaluated.All flow rates yielded within specifications with +/- 20% tolerance, the reported fast flow was not replicated.Root cause could not be determined.All information reasonably known as of 09-may-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: CB006C HYHSURGPN,400X2-14,CBCMBO,-,OQ,5
• Common Device Name: ELASTOMERIC - ON-Q WITH BOLUS
• 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: 13942819
• Report Number: 2026095-2022-00024
• Device Sequence Number: 6431707
• Product Code: MEB
• UDI-Device Identifier: 00193494468576
• UDI-Public: 00193494468576
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 03/27/2024
• Device Model Number: CB006C
• Device Catalogue Number: N/A
• Device Lot Number: 30155149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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: 0.02% ROPIVICAINE
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG