MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RCI SHER-I-BRONCH; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 02634-01

Device Problem Break (1069)

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

Event Date 07/31/2020

Event Type  malfunction  

Event Description

Certified register nurse assistant (crna) was in the process of intubating patient for surgery when connector piece for double lumen et tube broke.

• Brand Name: HUDSON RCI SHER-I-BRONCH
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; po box 12600; durham NC 27709
• MDR Report Key: 10384310
• MDR Text Key: 202178775
• Report Number: 10384310
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 02634-01
• Device Lot Number: 73J1900749
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Weight: 70