MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND, 400 ML X 1-7 +5 ML BOLUS/60 MIN; ELASTOMERIC - COMBO

Model Number	CB005
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 17-sep-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).Device not returned.
Event or Problem Description
Fill volume: 400 ml.Flow rate: 7 ml/hr.Procedure: unknown.Cathplace: unknown.It was reported that a patient called his anesthesiologist reporting that after pushing the bolus button on the pain ball, the contents emptied into his shoulder.The patient went to the emergency room to be evaluated.The pump was connected on (b)(6) 2018 and the patient sent home.The doctor stated that the pump was set to 7 cc/hr.No further information provided.

• Brand Name: ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND, 400 ML X 1-7 +5 ML BOLUS/60 MIN
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7892998
• Report Number: 2026095-2018-00095
• Device Sequence Number: 19272025
• Product Code: MEB
• UDI-Device Identifier: 30680651134739
• UDI-Public: 30680651134739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: Lay User/Patient
• Device Model Number: CB005
• Device Catalogue Number: 101347300
• Device Lot Number: UNKNOWN
• 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: 08/31/2018
• Initial Report FDA Received Date: 09/20/2018
• Patient Sequence Number: 1