MAUDE Adverse Event Report: I-FLOW LLC ECHOLONG CONTINUOUS ECHOGENIC NEEDLE/CATHETER; ANESTHESIA CONDUCTION KIT

Model Number ELL18100TG

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: right knee nerve block.Cathplace: saphenous nerve block.It was reported by a nurse that a catheter sheared during a nerve block procedure."the catheter was inserted through the needle until the position on the nerve was reached.When the needle was being withdrawn.It was caught in the catheter." a stylet was used when inserting the catheter.No resistance was met when inserting the catheter through the needle and the catheter was withdrawn while the needle was still in place, but the needle could not be pulled.No pt injury or medical intervention was required as a result of the incident, the pt was reported to be in normal post-op condition.The catheter was discarded before it could be collected and returned.The reporter could not confirm the lot number as it was not recorded.

Manufacturer Narrative

Method: the device is not available for return as the hospital staff disposed for the device before it could be collected for return to i-flow for eval.Results: as no device was available for an eval and no methods were performed; results cannot be obtained.Conclusions: since the device was not returned to i-flow for eval, we are unable to determine the cause for the reported event.As the catheter was discarded and an actual lot number for the suspect device was unavailable.The reporter gave a potential lot number of 0201180498 as she believes that it was the same as an unused device that she had available.I-flow will conduct a device history record review for the potential lot number (0201180498).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 investigations.

• Brand Name: ECHOLONG CONTINUOUS ECHOGENIC NEEDLE/CATHETER
• 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: 4152414
• MDR Text Key: 4909984
• Report Number: 2026095-2014-00192
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111355
• 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 Model Number: ELL18100TG
• Device Catalogue Number: 103922400
• 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
• 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: NAROPIN 0.5%
• Patient Age: 89 YR
• Patient Weight: 75