MAUDE Adverse Event Report: PAJUNK SONOPLEX STIM; CATHETER, CONDUCTION, ANETHETIC

Lot Number 1251

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Multiple pajunk sonoplex stims have been found to have leaks in the tubing connected to the iv during attempted nerve block prior to surgical procedures.No pt harm, however, multiple pts have had to be stuck a second time due to the leaking.

• Brand Name: SONOPLEX STIM
• Type of Device: CATHETER, CONDUCTION, ANETHETIC
• Manufacturer (Section D): PAJUNK; 6611 bay circle, ste 140; norcross GA 30071
• MDR Report Key: 7789106
• MDR Text Key: 117481456
• Report Number: MW5079183
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Lot Number: 1251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention