MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUE LINE ULTRA (BLU); TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/800/075CZ

Device Problem Gas/Air Leak (2946)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

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 during clinical tracheotomy, on (b)(6), 2022, the tracheostomy tube and accessories were replaced.There was a slow air leak after filling the air bag.The air leak could lead to insufficient ventilation and a risk of hypoxia that could cause serious injury.Device was discarded and replaced with a new one, without causing harm to the patient.No patient injury was reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA (BLU)
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; zhongshan city; minneapolis, MN 55442
• MDR Report Key: 15756142
• MDR Text Key: 303276343
• Report Number: 3012307300-2022-26919
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 4127301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female