MAUDE Adverse Event Report: HALYARD HEALTH - IRVINE CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER; ANESTHESIA CONDUCTION KIT

Model Number TBT02100ST

Device Problem Split (2537)

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

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Methods: the device was reported as not available for return and analysis.However a review of the device history record (dhr) was conducted for the reported mode and lot number.Results: inspection records for the (b)(4) catheter show no rejections recorded during the inspection performed.In process evaluation was performed and no root cause was identified for damage to the catheter as the assessment did not find any activity in the manufacturing process that could have led to affect the integrity of the components inside the tray.Conclusion: the device was not returned to (b)(4) for testing; therefore we are unable to determine a cause for the reported incident.The dhr assessment did not find any activity in the manufacturing process that could have led to the reported incident, there were no rejections recorded during the inspection.Additional information has been requested, however not yet received.Should additional information pertinent to this event become available, halyard will submit a follow-up report.Please note: the spirol catheter belongs to a peripheral nerve block tray that is assembled for (b)(4), and the suspect catheter mentioned in this incident is a component of the tray and an (b)(4) product.For this catheter, the product code is bso, and the 510k number is k133316.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending.Not returned to mfg.

Event Description

A catheter break was reported and further described as a catheter came apart while inside a patient.Further information was not reported and the device is not available for analysis.Photographic images were provided by the reporter and the catheter appears to be broken in several pieces.

• Brand Name: CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HALYARD HEALTH - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT, INC.; 6620 memorial place; suite 100; tucson AZ 85756
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5209673
• MDR Text Key: 31027920
• Report Number: 2026095-2015-00313
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: TBT02100ST
• Device Catalogue Number: 104077800
• Device Lot Number: 0202168068
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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