MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TRACHEOBRONCHIAL SUCTION CATHETER

Model Number Z210-16

Device Problem Gas/Air Leak (2946)

Patient Problem Ventilator Dependent (2395)

Event Date 01/09/2021

Event Type  Injury  

Event Description

Information was received indicating that the portex catheters suction pro leaked.When installing the closed suction system in the tube after intubation, in the part of the closed suction probe, there was a noise that appeared to leak.The change to a new closed suction system was carried out.Product was discarded due to contamination covid 19.

• Brand Name: PORTEX
• Type of Device: TRACHEOBRONCHIAL SUCTION CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11310564
• MDR Text Key: 231300937
• Report Number: 3012307300-2021-01132
• Device Sequence Number: 1
• Product Code: OFR
• UDI-Device Identifier: 15019315046919
• UDI-Public: 15019315046919
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K923559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: Z210-16
• Device Lot Number: 3975210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening