MAUDE Adverse Event Report: KIMBERLY-CLARK/ HALYARD ON-Q NERVE BLOCK TRAY

Lot Number 0202446910

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Event Description

The anesthesiologist place the stimulating needle in the pt.The anesthesiologist asked the tech to aspirate.While aspirating, air was drawn into the syringe.No air is to be aspirated into the syringe.Route: nerve block.Therapy start date: (b)(6) 2016.Therapy end date: (b)(6) 2017.Diagnosis or reason for use: continuous stimulating nerve block- pain relief.

• Brand Name: ON-Q NERVE BLOCK TRAY
• Type of Device: ON-Q NERVE BLOCK TRAY
• Manufacturer (Section D): KIMBERLY-CLARK/ HALYARD
• MDR Report Key: 6245321
• MDR Text Key: 64929649
• Report Number: MW5067189
• Device Sequence Number: 1
• Product Code: OGJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2017
• Device Lot Number: 0202446910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 18GA X 4 IN NEEDLE 20GA AND 24 IN CATHETER. ; ECHOGENIC STIMULATING NERVE BLOCK TRAY,; ON-Q PAIN RELIEF SYSTEM, T-BLOC CONTINUOUS,
• Patient Age: 60 YR