MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ON-Q PAIN RELIEF SYSTEM; PUMP, INFUSION, ELASTOMERIC

Lot Number 9110911

Device Problems Burst Container or Vessel (1074); Disconnection (1171)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

While mixing a on-q pump, the syringe disconnected from the ball while injecting the bupivacaine.The drug ended up spraying all over the iv tech's face.Some got into their eyes, but thankfully they were wearing prescriptive lens.Feedback and care was provided to the employee.Multiple technicians have reported that the on-q device can become easily stripped if over tightened, and that there is a needed amount of force to pump up the elastomeric ball.Fda safety report id# (b)(4).

• Brand Name: ON-Q PAIN RELIEF SYSTEM
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 12779645
• MDR Text Key: 280711516
• Report Number: MW5105186
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 9110911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2021
• Patient Sequence Number: 1