MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFS55
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Airway Obstruction (1699); Hypoxia (1918); Respiratory Distress (2045)
Date of Event	02/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a patient with a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube was reported to have breathing difficulties and secretion color changes.Measures were taken to ensure the patients airway with secretions coming from around the tube.An emergent trach tube was performed with an old, sterilized tube but three hours later, the same breathing difficulties occurred.A second tube change out was performed.There were no further reported adverse effects.
Event or Problem Description
Additional information on complaint of tracheostomy|silicone - bivona tubes neo/ped flextend leaking causing patient secreations and difficulty breathing.Summary in h 10.
Additional Manufacturer Narrative
Additional information received from mother on device makes file now serious injury reportable, as lower oxygen saturations, oxygen therapy, bagging, along with nebulizers and emergent tracheostomy change.This file is now serious injury reportable.Device has been decontaminated and will be investigated.Lot number provided and updated in corrective report.
Additional Manufacturer Narrative
Additional information: h10.Additional information received they tried to put the patient on a nebulizer with oxygen and on a cough assist machine to bring out the secretions from the lungs, however no secretions came out.The old tube was replaced back on the patient for 1.5 weeks because the patient's saturations were dropping.The customer identified cuff discoloration".
Additional Manufacturer Narrative
Two (2) samples were received to perform an investigation.Visual inspection was performed at 12 inches under normal lighting and one cuff was found completely broken.Functional testing was done using an air cuff symmetry test and leak test.When inflating the unit with air, the cuff only inflated on one side.The cuff was manipulated per instructions for use (ifu) and the whole cuff inflated.Air cuff symmetry test performed found the device to be within specification.No problem was found.Review of the manufacturing process found that the process was performed according to procedure by trained personnel.As a preventive action, production personnel were notified by quality engineer of the reported defect.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.No root cause could be determined as the complaint could not be confirmed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• Manufacturer (Section G): NULL; 6000 nathan lane n; minneapolis,, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, mn ; 3833310
• MDR Report Key: 9960354
• Report Number: 3012307300-2020-02984
• Device Sequence Number: 3354815
• Product Code: JOH
• UDI-Device Identifier: 10351688518651
• UDI-Public: 10351688518651
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/17/2022

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: Lay User/Patient
• Device Expiration Date: 07/20/2024
• Device Model Number: 67PFS55
• Device Catalogue Number: 67PFS55
• Device Lot Number: 3853408
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 04/22/2020; 07/14/2022
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/19/2020; 06/16/2020; 09/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown