MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,ON-Q-TBLOC,NDLCTH,-,2",5; REGIONAL ANESTHESIA

Model Number	TB050ST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.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: not applicable, flow rate: not applicable, procedure: ankle surgery, cathplace: popliteal nerve block.It was reported that when the catheter was pulled out from the needle, it became stuck and then sheared.The doctor removed the entire device and restarted the block with a new device.The patient was reported to have no injuries as a result of the procedure.Additional information received on 12-jan-2017 verified that this device is the usual t-bloc catheter.It was noted that it sheared while they attempted removal of the needle.
Additional Manufacturer Narrative
Date returned to manufacturer.A visual inspection found the catheter was returned split in half approximately several inches proximal to the 4th markings.The catheter was examined under a microscope magnified at 2x.The edges of the catheter indicate that a sharp object was used.The evaluation summary concludes that a shear was observed at the catheter.The edges of the catheter indicate that a sharp object was used.Based on the complaint description and sample evaluation the root cause is incorrect product handling.The sample investigation concluded that catheter was examined under a microscope magnified at 2x which indicates sharp object was used which had shear at the edges of the catheter.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).

• Brand Name: SURGPN,ON-Q-TBLOC,NDLCTH,-,2",5
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6263583
• Report Number: 2026095-2017-00008
• Device Sequence Number: 849709
• Product Code: MEB
• UDI-Device Identifier: 10680651407914
• UDI-Public: 10680651407914
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K073187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2017

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: TB050ST
• Device Catalogue Number: 104079100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 03/15/2017
• Patient Sequence Number: 1