MAUDE Adverse Event Report: I-FLOW, LLC PERIPHERAL NERVE BLOCK SUPPORT TRAY; ANESTHESIA CONDUCTIO KIT

Model Number TBT03100ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Procedure: unk - anp.Cathplace: unk - anp.It was reported by an i-flow product representative that a t-bloc spirol catheter shredded while removing the stylet.The damaged catheter was removed from the patient with no further patient consequence or medical intervention.

Manufacturer Narrative

Method: the device was reported to be returning for analysis, but pending receipt.A sample photograph was provided for a visual view.A review of the device history record is currently in progress for the lot number provided.Results: results will be provided once the evaluation and investigation have been completed.Conclusions: at this time the investigation is still in progress and the device is pending receipt.Once the device is received, testing will be performed.A follow-up report will be submitted once the investigation is completed.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, 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: PERIPHERAL NERVE BLOCK SUPPORT TRAY
• Type of Device: ANESTHESIA CONDUCTIO KIT
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4138728
• MDR Text Key: 21525622
• Report Number: 2026095-2014-00188
• 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: 09/04/2014

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 Expiration Date: 06/30/2015
• Device Model Number: TBT03100ST
• Device Catalogue Number: 104078100
• Device Lot Number: 0201424935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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: N/A