MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,ON-Q-TBLOC,ECTUHY,-,4",5; REGIONAL ANESTHESIA

Model Number	TBT02100T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
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.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).Device not returned.
Event or Problem Description
Halyard received a single report that referenced two different incidents, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 2026095-2017-00010 for the first patient.Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: paravertebral block.It was reported that a catheter broke off inside a patient.There was no reported patient injury.No further information was received.

• Brand Name: SURGPN,ON-Q-TBLOC,ECTUHY,-,4",5
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6301783
• Report Number: 2026095-2017-00011
• Device Sequence Number: 11189928
• Product Code: CAZ
• UDI-Device Identifier: 30680651407840
• UDI-Public: 30680651407840
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K073187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2017

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: TBT02100T
• Device Catalogue Number: 104078400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/03/2017
• Patient Sequence Number: 1