MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; ENDOSCOPIC BITE BLOCK

Model Number 1140

Device Problems Device Slipped (1584); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Intubated patient had bite block in his mouth ("scorpion" type? not sure the official name).Upon doing mouth care at 6 pm, the pca (patient care assistant) helping me noticed that the green part that goes between patient's teeth was in his mouth and was no longer attached to the long white part that comes out of the mouth.The white part was found in the bed by patient's neck.Bite block was intact most of the shift as patient requires frequent mouth care.

• Brand Name: HUDSON RCI
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12959914
• MDR Text Key: 281916674
• Report Number: 12959914
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1140
• Device Lot Number: UNKNOWN
• 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: 11/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other