MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES BLUSELECT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 101/800/070CZ

Device Problem Difficult to Remove (1528)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that during training, when removing the purple tube obturator the distal part of the obturator is getting blocked and is difficult to remove it completely out of the tube.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Additional information: g5 and expiration date.E4 is unknown.No problem or issues were identified during the device history record review.A sample and pictures were received for evaluation.The sample was received without its original packaging.During visual inspection, it was noticed that inside of the tube there was a flash which slightly reduced inner diameter of tracheostomy tube.The flash caused reported difficulties when obturator was inserted or removed from tracheostomy tube.Such defect is not in compliance with visual standard.Returned sample was tested by ball bearing dedicated for 7.0mm size.It was found that steel ball cannot go through tracheostomy tube and it was stacked in area where tube is connected with a 15mm connector.Complaint history was checked and this is the first reported incident.Current production was checked by manufacturing quality engineer and no fault was found, parts were acceptable both visually and by functional testing, ball bearing passed.Based on above investigation tracheostomy tube with flash inside is considered to be isolated incident.Root cause is unknown.During manufacturing process there are following checks which should detect reduced internal diameter of tracheostomy tube: sample functional checks of inner diameter by ball bearings (steel ball must go trough whole tube length and 100 percent visual inspections (after molding and during tracheostomy tube assembly process).To increase awareness about this issue a quality alert was placed on tube molding and tube assembly.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• Type of Device: TUBE, TRACHEAL (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; minneapolis, MN 55442
• MDR Report Key: 13153270
• MDR Text Key: 283685212
• Report Number: 3012307300-2021-13345
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076073
• UDI-Public: 15019517076073
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: 101/800/070CZ
• Device Catalogue Number: 101/800/070CZ
• Device Lot Number: 3895101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1