MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CB006
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	02/26/2018
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 28-mar-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: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown.It was reported that an elastomeric pump delivered solution faster than expected.The red tab on the bolus was not removed.However, the patient was reported to have no injury.
Additional Manufacturer Narrative
Correct data- patient identifier, date rec¿d by mfr.All information reasonably known as of (b)(6) 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.This product incident is documented in the halyard health 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 a halyard health product is defective or caused serious injury.

• Brand Name: ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7388301
• Report Number: 2026095-2018-00043
• Device Sequence Number: 1314868
• Product Code: MEB
• UDI-Device Identifier: 30680651134746
• UDI-Public: 30680651134746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: Health Professional
• Device Model Number: CB006
• Device Catalogue Number: 101347400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 05/21/2018
• Patient Sequence Number: 1