MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM T-BLOC CONTINUOUS ECHOGENIC; REGIONAL ANESTHESIA

Model Number	TBT02100ST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was reported to be available but was not returned.The device history record for the reported lot number, 0202650452, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 09-jul-2017 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).Device not returned.
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: shoulder procedure, cathplace: interscalene.It was reported the catheter was threaded through the needle.When the anesthesiologist tried to remove the needle and guidewire, the catheter broke at the tip.A second tray was opened and the block was successfully completed.There was no reported patient injury.Additional information received 15-june-2017 stated the catheter broke inside the patient.The broken catheter segment remained inside the patient.No further information to be provided.

• Brand Name: ON-Q PAIN RELIEF SYSTEM T-BLOC CONTINUOUS ECHOGENIC
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6708774
• Report Number: 3006646024-2017-00015
• Device Sequence Number: 10982381
• Product Code: CAZ
• UDI-Device Identifier: 30680651407789
• UDI-Public: 30680651407789
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K073187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: TBT02100ST
• Device Catalogue Number: 104077801
• Device Lot Number: 0202650452
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/12/2017
• Patient Sequence Number: 1