MAUDE Adverse Event Report: HALYARD CONTINUOUS TRAY WITH 100MM NEEDLE, NON-STIMUL; ANESTHESIA CONDUCTION KIT

Model Number TBT03100T

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  Injury  

Event Description

Procedure: total knee replacement; cathplace: femoral nerve block.It was reported that a catheter from a t-bloc peripheral nerve block support tray uncoiled and sheared at the tip during insertion; when trying to reposition the catheter, resistance was met.The incident was described by the physician in the following manner.The catheter made it to the tip of the needle but could not be pushed further, so the anesthesiologist attempted to reposition the needle.The doctor reported that he pulled back a little on the catheter and was met with resistance.The doctor then pulled a little more and more resistance was met.At this point the doctor saw the black tip of the catheter outside of the needle.The doctor pulled harder to remove the catheter and it sheared off.The doctor retrieved the catheter tip from the patient and completed the nerve block using a new catheter from a new t-block tray kit.The doctor reported that there was no difficulty using the new catheter and that the uncoiling of the catheter incident was unusual in that the doctor does not normally retract the catheter once it is placed.In this particular case, the doctor did not like where the catheter was moving and therefore attempted to reposition the device.The catheter is reported to be available for evaluation.No patient injury occurred.

Manufacturer Narrative

Method: the device was reported to be returned for an evaluation and at this time (b)(4) is pending receipt of the device.A review of the device history record (dhr) is in progress for the reported lot number.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.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.The patient's weight was not reported other than stating that the patient was "not obese".The patient's age was not reported other than stating that the patient's age was (b)(6).Please note: the spirol catheter belongs to a peripheral nerve block tray that is assembled by (b)(4), and the suspect catheter mentioned in this incident is a component of the tray and an (b)(4) product.(b)(4).

• Brand Name: CONTINUOUS TRAY WITH 100MM NEEDLE, NON-STIMUL
• 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: 4462253
• MDR Text Key: 22032847
• Report Number: 2026095-2015-00025
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: TBT03100T
• Device Catalogue Number: 104078700
• Device Lot Number: 0201441654
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: DRUG: LOCAL ANESTHETIC
• Patient Outcome(s): Required Intervention