MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ONQ PAIN RELIEF SYSTEM DELIVERING DEVICE; PUMP, INFUSION, ELASTOMERIC

Lot Number 30170370

Device Problems Disconnection (1171); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Pt.Reports in a post op call with nurse that the tubing disconnected from the on-q system where it feeds into the rate adjustment.Pt.Reported no pain during post op call.Catheter was removed with nurse instruction and patient presented device at follow up appt.Per nurse no issues noted with device except tubing had been severed ¿ unsure if possible, patient error by pulling on tubing.Nurse disposed of on-q device after inspecting and unable to submit for further review.

• Brand Name: ONQ PAIN RELIEF SYSTEM DELIVERING DEVICE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16411120
• MDR Text Key: 310094211
• Report Number: MW5115065
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 02/14/2023

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: 30170370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUPIVACAINE
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White