MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE TRACHEAL

Model Number 100/111/025

Device Problem Device Damaged Prior to Use (2284)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

End user: (b)(6).

Event Description

It was reported that there was broken plastic upon arrival.

Manufacturer Narrative

Other, other text: two (2) samples were returned for evaluation; they were in used condition.The returned samples were visually inspected; broken connectors were observed in both samples.The complaint was confirmed.The root cause for the fractured components is undetermined; it is believed that the damage occurred after leaving the facility.Customer complaint notification was performed on (b)(6)2022 to personnel to explain the reported failure mode.No lot number was provided for performance of a device history record review.No patient injury was reported.(updated b5 and h6), corrected data: labeled for single use was answered incorrectly, in the initial report.(h5).

Event Description

There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

• Brand Name: PORTEX
• Type of Device: TUBE TRACHEAL
• 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; rm401, (gems bldg, gunja-dong); minneapolis, MN 55442
• MDR Report Key: 13470509
• MDR Text Key: 285240349
• Report Number: 3012307300-2022-02760
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 15019315018848
• UDI-Public: 15019315018848
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K790312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/111/025
• Device Catalogue Number: 100/111/025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1