MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 94815

Device Problems Material Discolored (1170); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Date 08/02/2018

Event Type  malfunction  

Event Description

When rn was administering the medication, the patient reported slight discomfort at the ng site.Upon assessment, the rn noticed the anchor looked out of place and when tried to assess the site, the tube got inadvertently removed.Upon inspection, the balloon was brown and missing a small portion of it.

• Brand Name: HALYARD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7867974
• MDR Text Key: 119937681
• Report Number: 7867974
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2018,08/16/2018

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 Model Number: 94815
• Device Catalogue Number: 0112-14LV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 63