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

Model Number TBT02100ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Procedure: unk - anp.Cathplace: interscalene block.It was reported by an anesthesiologist that a catheter from a regional anesthesia tray sheared during an interscalene block.During insertion of the catheter minimal resistance was met.Upon removal of the stylet, the stylet would not come out.When the needle was removed, he noticed there was a slight shearing of the catheter.The catheter was completely removed from the pt.Another kit was used without further issue and there was no pt injury or med intervention required.Pt info is not available as the nurse could not recall specific details for the pt involved.Anp: asked not provided.

Manufacturer Narrative

Method: the suspect device was received for analysis.A review of the device history record is in progress.Results: evaluation and investigation results will be provided once they are completed.Conclusions: at this time the investigation and analysis are still in progress.A follow-up report will be submitted upon completion.Info from this incident will be included in our product complaint and mdr trend reporting sys.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 product code is bso and the 510k number is k133316.

• Brand Name: CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4148056
• MDR Text Key: 20012163
• Report Number: 2026095-2014-00193
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: TBT02100ST
• Device Catalogue Number: 104077800
• Device Lot Number: 0201416190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: ROPIVACAINE 30CC; SIMULATING NEEDLE