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

Model Number	CBI006
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202953435, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 16-nov-2018 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).
Event or Problem Description
Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 2026095-2018-00146 for the first event.It was reported by the physician that the patient's bolus button was stuck in the down position, resulting in the patient receiving a continuous bolus dose.The physician replaced the device with a different device.Per additional information received on 26-oct-2018 as the previous on-q device was finishing, without any reported issue, the nurse changed it for a new one.After that, the patient alerted the nurse to the issue with the bolus button remaining in the down position.The device was changed again and the patient again was receiving continuous bolus of ropivacaine due to a problem with the bolus button remaining in the down position.This device was swapped out for an electronic pump.There was no injury to the patient.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 2019 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
One on-q select-a-flow pca combo was received, partially full with the bolus indicator in the middle position with the button in the upward position.The pca button was refilled to the top.The button was depressed and expensed.The bolus button latched properly and dispensed the medication, the bolus had no issues refilling.The bolus volume test results yielded an average delivery amount, all results were within specifications.The investigation summary concluded that the bolus button functioned as intended and observed no issues.During pca safety bolus test and bolus volume testing, results met specifications.The root cause could not be identified since the device functioned as intended during sample evaluation, no defect was found; additionally, dhr review found no abnormal conditions that could have contributed to the reported incident.All information reasonably known as of (b)(6) 2019 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)(6).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 ON DEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8081304
• Report Number: 2026095-2018-00147
• Device Sequence Number: 16525889
• Product Code: MEB
• UDI-Device Identifier: 30680651134838
• UDI-Public: 30680651134838
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2019

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: 03/25/2020
• Device Model Number: CBI006
• Device Catalogue Number: 101348303
• Device Lot Number: 0202953435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 01/25/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/04/2019; 02/05/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE