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

Catalog Number 100/563/090

Device Problem Inflation Problem (1310)

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

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510k is unknown.A product sample was received and is awaiting evaluation and 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 preparation for a dilated tracheostomy, the components of the set were checked; leakage (a hole) at the cuff was noticed during the test block of the cannula.A completely new set had to be opened.No injury was reported.No patient involvement.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.The defected sample returned was accompanied by a certificate of decontamination.The sample for this complaint was sent to the manufacturing site, who will carry out a full investigation into the reported issue based on the sample which was returned.The root cause was not yet established.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.G4: date returned to manufacturer: 11/14/2022.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be performed.Two (2) photos were attached to the complaint created; these photos were provided by the customer.The photos were used to conduct the device analysis since the physical unit was received at cumbernauld site on the 21-nov-2022 and then forwarded to tijuana site for evaluation, by the time this investigation is being documented the unit has not been received in the tijuana site.Photo one shows a tracheostomy tube; in this photo the complete device is observed, but no damage or dysfunctional conditions that could cause the reported failure are observed.Photo two shows a close-up of the seal cuff where tear damage, cut, is visible in the cuff; the damage appears to have been created by sharp instrument as the cuff does not presents any other discrepancies, such as marks that would indicate stress on the cuff.Based on the analysis conducted with the submitted photos the unit presents a tear which is the cause that produced the leak failure on the unit as reported.After reviewing the mitigations that are performed during the manufacturing process to detect damage component, the most probable root cause is that the cut damaged on the cuff occurred after the product left the shm facility.No corrective actions are required because the mitigations on place were revised and are executing as is determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBES
• 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; minneapolis, MN 55442
• MDR Report Key: 15674765
• MDR Text Key: 307066265
• Report Number: 3012307300-2022-26275
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/563/090
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1