MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ON-Q PAIN MANAGEMENT SYSTEMS; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number PM010-A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2022

Event Type  Injury  

Event Description

When discontinuing onq pump today-most posterior catheter fractured inside patient.Fda safety report id# (b)(4).

• Brand Name: ON-Q PAIN MANAGEMENT SYSTEMS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 15855487
• MDR Text Key: 304293438
• Report Number: MW5113442
• Device Sequence Number: 2
• 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: 11/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PM010-A
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 30 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White