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

Model Number 40978

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

Unable to pass wire through the opaque/white portion of the equipment.

• Brand Name: HALYARD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 widward parkway; alpharetta GA 30004
• MDR Report Key: 7533236
• MDR Text Key: 108889019
• Report Number: 7533236
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651409789
• UDI-Public: (01)10680651409789
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: 40978
• Device Catalogue Number: 7170-20
• Device Lot Number: 0202833884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR