MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES MINITRACHEOSTOMY MINI-TRACH; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/461/000

Device Problems Positioning Failure (1158); Insufficient Information (3190); Failure to Eject (4010)

Patient Problems Perforation (2001); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Device lot number are unknown, no product 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 when the customer checked a ct image of the product during the use of it, he noticed the tube pierced the posterior wall of the trachea and was retained in the esophagus.He performed the puncture with a 16g tuohy needle to the patient, and then made a skin incision.After that, he used a dilator for the patient.The customer would like to know the role of (what is the meaning of) making a skin incision prior to the use of the dilator.

Manufacturer Narrative

Other, other text: no product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.(h6c, h6d, h6e) no lot number was provided for performance of a device history record review.

Manufacturer Narrative

Other, other text: no product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.(h6c, h6d, h6e) no lot number was provided for performance of a device history record review.

• Brand Name: PORTEX TUBES MINITRACHEOSTOMY MINI-TRACH
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 15536709
• MDR Text Key: 301102022
• Report Number: 3012307300-2022-20718
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/461/000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening