MAUDE Adverse Event Report: HALYARD ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU; ANESTHESIA CONDUCTION KIT

Model Number TBT01089T

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

Please reference: 2026095-2015-00118/ (b)(6).Procedure: shoulder scope.Cathplace: interscalene nerve block.It was reported that an anesthesiologist performed two separate procedure on two pts, and during each separate procedure the anesthesiologist experienced a catheter shearing.It was reported that the stylet wasn't "pulling out" after the catheter had been inserted.As the anesthesiologist was trying to pull the stylet back, the catheter started to shear.The catheters were removed on both pts and replaced with a catheter from another catheter kit in which "the stylet pulled out fine".The catheter for this reported incident is unavailable for return.Add'l info was received on 03/12/2015.It was reported that the shear of both catheters occurred during the removal of stylets.For the first incident, there was lot of resistance when pulling the stylet off the catheter.At this point, the needle was already pulled back (so not related to the needle).When the anesthesiologist pulled the stylet out, the catheter started shearing outside of the pt.The doctor had to replace the sheared catheter with a new catheter.No pt injury occurred.The lot number was not available.Add'l info was received on 03/18/2015.It was reported that no add'l info was available.

Manufacturer Narrative

Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.The instructions for use were reviewed.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Conclusions: the device was not returned to halyard for an eval; therefore we are unable to determine the cause for the reported event.No pt injury was reported.Per the reported info, the anesthesiologist met some resistance when pulling back the stylet.Please note: the spirol catheter belongs to a peripheral nerve tray that is assembled by halyard, and the suspect catheter mentioned in this incident is a component of the tray and an epimed product.For this catheter, the product code is bso and the 510k number is k133316.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for add'l investigations.See scanned page.

• Brand Name: ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HALYARD ; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4672429
• MDR Text Key: 5734565
• Report Number: 2026095-2015-00117
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TBT01089T
• Device Catalogue Number: 104078400
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1