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

Model Number TBT02100T

Device Problem Split (2537)

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

Event Date 06/23/2015

Event Type  Injury  

Event Description

Please reference: 2026095-20152-00198/15-00619(a).Procedure: asku.Cathplace: asku.It was reported that two incidents of a catheter break occurred during use.Incident #2 of 2: it was reported that the anesthesiologist threaded the catheter through the needle.The needle was then withdrawn from the patient.The anesthesiologist removed the stylet, the catheter came out with the stylet and the catheter shredded.The catheter had the coil stretched.It was reported that the physician was able to remove the entire catheter.The physician had to make an incision to remove the retained catheter from inside the patient.The anesthesiologist described, "difficulty in threading the catheter through the needle and withdrawing the catheter and needle together, but with the catheter remaining stuck." additional information was requested, however is not available at this time.The catheter is available for return.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) for the reported lot number is currently in process.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.Device return anticipated.

Event Description

Please reference: 2026095-2015-00198/15-00619(a).Additional information was received on 07/16/2015.The catheter was used for a femoral nerve block.After the surgical removal of the broken catheter, the patient responded "fine" with no complications.

Manufacturer Narrative

Method: the device was received and visually inspected.Also, the device history record and process review was performed for the lot number provided.Results: incoming inspection records found no rejections for this lot.There were no issues found reported by the quality auditor at the time of manufacture.Upon inspection the catheter was visually missing its distal tip and returned with the stylet.It appeared to be bent in several locations.The nylon coating had been sheared off from the proximal end tracking towards the catheters distal end.This is indicative of the needle being in place during attempted removal.Conclusion: based on the visual inspection it is believed that the corresponding needle remained in place during the attempted removal of the catheter, ultimately causing the catheter to shear.The root cause was determined to be the user not following precaution section number 5 in the spirol ifu (b-pi-009) (5.During catheter removal if resistance is encountered, stop, reposition the patient to open the vertebral interspaces and attempt removal.If further difficulty is encountered, fluoroscopy or x-ray may be indicated prior to further catheter manipulation.) it is suspected that the catheters in question sheared due to the physician's technique.Information from this incident has been included in our product complaint reporting systems for monitoring, tracking and trending purposes.

• Brand Name: ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE NON-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: 4917249
• MDR Text Key: 6027114
• Report Number: 2026095-2015-00199
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: TBT02100T
• Device Catalogue Number: 104078400
• Device Lot Number: 0202145814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 43