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

Model Number 100/897/080

Device Problem Break (1069)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/07/2022

Event Type  Injury  

Event Description

It was reported that the inner cannula partially dislodged and unable to be secured into place despite re-attempts.Patient became unstable, desaturating to 70s.Patient required ambu-bagging and dr.Returned to the bedside.Dr.Performed a bronch/tracheostomy swap and removed the old trach.The old trach is visibly broken/defective with potential to become dislodged and descend further into the patients airway.There was no patient injury reported.

Manufacturer Narrative

One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual testing was performed.Under visual inspection we noticed that white connector is separated from tube as described by customer.Condition of returned sample indicates poor user handling.The connector is very badly scratched around its whole diameter.It is not possible that connector left manufacturing site in such conditions.Connectors are manually bonded with tracheostomy tube as per manufacturing procedure with the help of solvent.Within this manufacturing process, there are several quality checks implemented for visual and functional inspection.The returned sample was inspected under magnification and presence of solvent was confirmed.Complaint history was checked and no trend of confirmed customer complaints were identified.Based on poor condition of connector this claim is considered to be user issue caused by poor handling with product.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE TRACH 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: 13715078
• MDR Text Key: 287003521
• Report Number: 3012307300-2022-04426
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/897/080
• Device Catalogue Number: 100/897/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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