MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC WITH DUAL SELECT-A-FLOW* 600 ML X 1-7 ML/HR + 1-7 ML/HR; ELASTOMERIC - SAF

Model Number	CB6007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.All information reasonably known as of 06-may-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 halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
Fill volume: 700 ml, flow rate: 1 to 3 ml/hr, procedure: pediatric vats performed on (b)(6) 2018, cathplace: top of the ribs.It was reported the patient experienced sustained axillary nerve apraxia after the use of the pump.The doctors were not sure if the use of the pump and catheter contributed to the symptoms.The patient was not sure when the symptoms started during the infusion process.The device was removed on (b)(6) 2018.The neurology team was consulted and physical therapy (pt) was initiated prior to transfer of the patient.No additional information.

• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7494622
• Report Number: 2026095-2018-00054
• Device Sequence Number: 16570257
• Product Code: MEB
• UDI-Device Identifier: 30680651134777
• UDI-Public: 30680651134777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other Health Care Professional
• Device Model Number: CB6007
• Device Catalogue Number: 101347700
• 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: 04/16/2018
• Initial Report FDA Received Date: 05/08/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THE 0.1% ROPIVACAINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Weight: 35