MAUDE Adverse Event Report: I-FLOW, LLC PERIPHERAL NERVE BLOCK SUPPORT TRAY; ELASTOMERIC PUMP

Model Number TBT03100ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

Fill volume: na.Flow rate: na.Procedure: femoral nerve block.Cathplace: femoral nerve.It was reported that a catheter had sheared.The physician had felt it is a little difficult to feed the catheter through the tip, he backed the needle out of the patient and then tried to pull back on the stylette to remove it.He could not remove the stylette from catheter, so the physician pulled the blue part of the stylette hard enough that it came off.He removed the spirol catheter from the patient and start the block over using a different needle and catheter.Upon closer inspection of the catheter once it was removed, it was visible it had sheared.The patient was reported to be doing fine.

Manufacturer Narrative

Method: the device was returned for analysis.The device evaluation is anticipated, but has not yet begun.A review of the device history record (dhr) is in progress at this time.Results: evaluation and investigation results will be provided once they are completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.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: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4259673
• MDR Text Key: 5014601
• Report Number: 2026095-2014-00172
• 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: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• 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
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• 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: NA.
• Patient Age: 51 YR
• Patient Weight: 166