MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX OXYGEN AND MEDICATION DELIVERY CONNECTOR; CONNECTOR, AIRWAY (EXTENSION)

Model Number 66-1991

Device Problem Failure to Disconnect (2541)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number, device manufacture date, and 510k are unknown.No information has been provided to date.Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the it was so challenging for the doctor to remove the scope from the swivel connector, the device sheared.Concomitant medical products/therapies reported were: bf-1th190 and bf-uc180f.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.

• Brand Name: PORTEX OXYGEN AND MEDICATION DELIVERY CONNECTOR
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16481492
• MDR Text Key: 310692837
• Report Number: 3012307300-2023-01994
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66-1991
• Device Catalogue Number: 66-1991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1