MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) INTRODUCER KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number MANUFACTURER NUMBER: 98434

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

Peg tube being placed and dilator sheath separated on removal.Fda safety report id # (b)(4).

• Brand Name: INTRODUCER KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 13087504
• MDR Text Key: 282896689
• Report Number: MW5106276
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2021

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 Catalogue Number: MANUFACTURER NUMBER: 98434
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Patient Sequence Number: 1