MAUDE Adverse Event Report: I-FLOW LLC CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA; ANESTHESIA CONDUCTION KIT

Model Number TBT02100T

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

Procedure: unk.Cathplace: saphenous nerve block.It was reported by an i-flow product sales rep, that an anesthesiologist reported an incident of a catheter becoming kinked and shearing during a nerve block procedure.While he was inserting the spirol catheter through the echo needle, he met resistance when he reached the tip of the needle.The physician attempted to reposition the catheter and as soon as he pulled back on the catheter, it kinked.After the catheter kinked the anesthesiologist removed the catheter and the catheter sheared during removal.The needle was still in place when he pulled back on the catheter.All catheter pieces were removed and no injury occurred.A new kit was used to complete the nerve block.No other medical intervention was provided.

Manufacturer Narrative

Method: the device was received for an eval.A visual inspection was performed.The device lot number is unavailable, as the info was not saved by the hospital nurse staff.Therefore, a review of the device history record (dhr) cannot be conducted.Results: at this time the results are pending the completion of the eval and investigation which is currently in procedures.Conclusions: a conclusion is not yet available as the investigation and eval of the product is still in progress, and has not been completed.Once the investigation and device analysis are completed a follow-up report will be submitted.Info from this incident will be included in product complaint and mdr reporting system.Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.Please note: the spirol catheter belongs to a peripheral nerve block tray that is assembled by kimberly clark, and the suspect catheter mentioned in this incident is a component of the tray and an epimed product.For this catheter, the 510k number is k133316.

• Brand Name: CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4138707
• MDR Text Key: 18926102
• Report Number: 2026095-2014-00190
• 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: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TBT02100T
• Device Catalogue Number: 104078400
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 4INCH ECHO NEEDLE; DRUG: ROPIVACAINE 0.5%
• Patient Age: 74 YR