MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 101/870/070CZ

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

D4: lot number, expiration date, and h4: manufacture date are unknown; no information has been provided to date.H3 other: device was reported as unavailable for return for investigation.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 tracheostomy tube was inserted on the (b)(6) 2023.Within 10 days the writing has rubbed off on the pilot balloon.There was patient involvement but no patient harm.

• Brand Name: BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18352797
• MDR Text Key: 331078287
• Report Number: 3012307300-2023-12089
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 55019517077986
• UDI-Public: (01)55019517077986
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101/870/070CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1