MAUDE Adverse Event Report: HALYARD - IRVINE PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING; ANESTHESIA CONDUCTION KIT

Model Number TBT03100ST

Device Problem Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Procedure: total knee replacement cathplace: adductor canal block.It was reported that an incident of a spirol catheter break occurred.It was reported as, "coil came out, when the needle was withdrawn from the patient during the procedure".The catheter was removed and the procedure was redone.No patient injury was reported.The device was reported as discarded.Additional information was received on 05/05/2015: during the removal of the needle after the catheter was in place, the catheter shredded and exposed the coil.The entire catheter was removed from the patient.No part of the catheter was left in the patient.The anesthesiologist used a 4 inch needle from one kit and a 20g spirol catheter from a separate kit.The exact date of the incident and the lot number is reported as unavailable.It was reported that the patient's gender, age and weight will not be provided.

Manufacturer Narrative

(b)(4).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.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 evaluation, therefore we are unable to determine the cause for the reported event.No patient injury was reported.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.Please note: the spirol catheter belongs to a peripheral nerve block 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.

• Brand Name: PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4766704
• MDR Text Key: 19496349
• Report Number: 2026095-2015-00146
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TBT03100ST
• Device Catalogue Number: 104078100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• 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
• Treatment: ECHOGENIC NEEDLE 4IN 18G