MAUDE Adverse Event Report: I-FLOW LLC CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE; NERVE BLOC KIT

Model Number TBT02100T

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Procedure: total knee replacement.Cathpath: femoral nerve block.It was reported that a catheter stylet was stuck, and during removal the catheter sheared.Threading the catheter was normal and resistance was not met.It was only when the crna attempted to remove the stylet that the catheter then became stuck.After the third attempt the stylet came out, but sheared the catheter.The inner coil completely pulled out of the catheter.It was reported that the catheter was removed without difficulty and the entire catheter was accounted for after the catheter removal.

Manufacturer Narrative

Method: the device is not available for return as the hospital staff disposed of the device before it could be collected for return.A review of the device history record is being conducted for the lot number reported.Results: as the device was unavailable for an eval, no methods were performed and results cannot be obtained.Conclusions: since the device was not returned to i-flow for eval, we are unable to determine an exact cause for the reported event.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 product code is bso and the 510k number is k133316.If additional info pertinent to this complaint is received, a follow-up report will be submitted.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigation.

• Brand Name: CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE
• Type of Device: NERVE BLOC KIT
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4152393
• MDR Text Key: 17617907
• Report Number: 2026095-2014-00191
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: TBT02100T
• Device Catalogue Number: 104078400
• Device Lot Number: 0201374569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: NOT PROVIDED.
• Patient Age: 63 YR