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

Model Number	100/897/080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-04426
• Device Sequence Number: 6363212
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown