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

Model Number 101/860/080CZ

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

One smiths medical tracheostomy|pvc - portex tubes bluselect was returned for analysis.Under visual inspection we noticed that pilot balloon was detached from inflation line.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

Event Description

Information was received indicating that while in use of a smiths medical tracheostomy|pvc - portex tubes bluselect, it was noted that the inflation line got detached from the pilot balloon.No patient consequences were reported.No adverse effects were reported.

Manufacturer Narrative

H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection was performed.Visual inspection: the returned sample was visually inspected at 12? to 16? and normal conditions of illumination according site visual inspection procedure md01-003 rev.102.Inflation line detached from pilot balloon was observed and a lack of solvent was detected; thus the failure mode reported is confirmed.Based on the analysis conducted in the sample provided, inflation line detached failure mode was confirmed.Therefore the occurrence of this failure condition could be caused by: not enough thf solvent at joint.The cause of the reported problem was traced to the manufacturing process.Dmrs, ncrs, ets review, revealed there were no issues, nonconformance reported during the manufacture of this lot.

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEOSTOMY
• 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: david halverson ; 6000 nathan lane north; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 12525421
• MDR Text Key: 273089993
• Report Number: 3012307300-2021-09580
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• 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
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1