MAUDE Adverse Event Report: ON-Q PAIN RELIEF SYSTEM; PAIN PUMP

Catalog Number 400X4D

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 04/17/2017

Event Type  malfunction  

Event Description

Upon removal of on-q pain catheter from left lateral axilla, tip was not intact.Device removed in surgeon's office on post op visit; catheter break in situ.Tip retained.No adverse reaction to patient.Dates of use: (b)(6) 2017.Diagnosis or reason for use: a/p breast reconstruction.

• Brand Name: ON-Q PAIN RELIEF SYSTEM
• Type of Device: PAIN PUMP
• MDR Report Key: 6543778
• MDR Text Key: 74490575
• Report Number: MW5069567
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2017

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 Expiration Date: 08/11/2019
• Device Catalogue Number: 400X4D
• Device Lot Number: 0202629155 OR 0202634729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2017
• 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
• Treatment: NATRELLE INSPIRA BREAST IMPLANT
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 86