MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number PM020-A

Device Problem Defective Device (2588)

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

Event Date 07/18/2019

Event Type  malfunction  

Event Description

During the procedure, the on-q catheter failed after being primed to allow administration of anesthetic.Due to malfunction the device was removed.

• Brand Name: HALYARD
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8910153
• MDR Text Key: 154867497
• Report Number: 8910153
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/02/2019

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 Catalogue Number: PM020-A
• Device Lot Number: 0202959302
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Weight: 97