MAUDE Adverse Event Report: HALYARD ON-Q PAIN RELIEF SYSTEM WITH ONDEMAND

Lot Number 0202807691

Device Problems Leak/Splash (1354); Device Inoperable (1663)

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

Event Date 01/23/2018

Event Type  Injury  

Event Description

The on-q pain relief system with on demand produced by halyard has a malfunctioning cap.At the end of the lining, the cap is not staying secure resulting in the on-q device leaking.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH ONDEMAND
• Type of Device: ON-Q PAIN RELIEF SYSTEM
• Manufacturer (Section D): HALYARD; alpharetta GA
• MDR Report Key: 7221363
• MDR Text Key: 98469233
• Report Number: MW5074874
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/24/2018

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 Operator: Health Professional
• Device Lot Number: 0202807691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• 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