MAUDE Adverse Event Report: HALYARD ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE STIMULAT.; ANESTHESIA CONDUCTION KIT

Model Number TB100ST

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2014

Event Type  malfunction  

Manufacturer Narrative

Method: the device will not be returned for an analysis.The lot number was received and a review of the device history record (dhr) and process evaluation were conducted.Results: as the device was not available for an evaluation, testing results cannot be obtained.Per the dhr review the lot met manufacturing specification at release.The process review was performed and the lot was manufactured according to approved procedures.The process evaluation performed indicated no root cause was identified for the function and damage to catheter as the assessment did not find any activity in the incoming inspection and manufacturing process that could have led to affect the integrity of the components inside the tray.Conclusions: the device was not returned to (b)(4) for an evaluation, therefore we are unable to determine a cause for the reported event.If additional information pertinent to this complaint is received, halyard will submit a follow-up report.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Event Description

Procedure: left humerus fracture repair.Cathplace: interscalene nerve block.Please reference: 2026095-2014-00252/14-00991.Report 2 of 2: tray 2.A nurse reported that a catheter broke into two pieces during use, by an anesthesiologist, on a patient during a nerve block.After removing the stylet and needle, the anesthesiologist gently pulled back the catheter.At this point, the catheter broken into two pieces at the insertion point near the skin.The anesthesiologist was able to remove the catheter pieces and the device was reported as discarded.It is unknown which catheter was used from which model number t-bloc tray, therefore both model numbers are being investigated by halyard.No injury or medical intervention was reported.

• Brand Name: ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE STIMULAT.
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4317106
• MDR Text Key: 19372197
• Report Number: 2026095-2014-00253
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: TB100ST
• Device Catalogue Number: 104079200
• Device Lot Number: 0201416069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Patient Age: 66 YR