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

Model Number TBT03100ST

Device Problems Stretched (1601); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Procedure: total knee.Cathplace: femoral block.It was reported by our sales representative that a catheter had broke during a femoral nerve block for a total knee procedure.This occurred when the physician was removing the stylet, the catheter had completely sheared from the middle to the end and the spring coiling on the inside of the catheter was stretched to the point of being flattened.The catheter sheared 3-4 inches outside of the patient to the distal end.The catheter was completely removed from the patient and a new needle and catheter had to be used to re-block the patient.There were no pieces of the catheter retained inside the patient.It was reported that the patient did not experience any injury or additional medical intervention as a result of this incident.

Manufacturer Narrative

Method: it was reported that the device sample was discarded.A review of the device history record (dhr) was conducted for the lot number reported.Results: as a device was not available for an evaluation, no methods were performed therefore; results cannot be obtained.Incoming inspection records for the catheter show no rejections recorded during inspection performed.Conclusions: at this time i-flow is further investigating the incident with the reported information received.A follow-up report will be filed when the investigation is complete.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.

• Brand Name: PERIPHERAL NERVE BLOCK SUPPORT TRAY
• 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: 4004805
• MDR Text Key: 4953907
• Report Number: 2026095-2014-00126
• 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: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: TBT03100ST
• Device Catalogue Number: 104078100
• Device Lot Number: 0201424935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NAROPIN (ROPIVACAINE) 0.2%