MAUDE Adverse Event Report: HALYARD HEALTH INC. INLINE SUCTION CATHETER; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Catalog Number REF 210

Device Problem Crack (1135)

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

Event Date 01/18/2020

Event Type  malfunction  

Event Description

Patient intubated with inline suction catheter in place.Patient vent popping off easily with cares/interventions.Noted inline to have crack in plastic that connects vent to patient's ett.Able to quickly change inline suction to fix issue.

• Brand Name: INLINE SUCTION CATHETER
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): HALYARD HEALTH INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9711007
• MDR Text Key: 179435966
• Report Number: 9711007
• Device Sequence Number: 1
• Product Code: BSY
• 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: 01/28/2020

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: REF 210
• Device Lot Number: M1828T507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2920 DA