MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBES; 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	01/24/2020
Type of Reportable Event	Malfunction
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.
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.
Event or Problem Description
Additional information on complaint of tracheostomy silicone -bivona neo/ped flextend leaking causing patient secretions and difficulty breathing.Summary in h-10.
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
Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: two (2) samples were received in used conditions, without their original packaging and with their certificate of safe handling.Visual inspection results: during the visual inspection, it was seen that one cuff was completely broken.Functional test: air cuff symmetry test was performed results: when inflating the unit with air, the cuff only inflated one side.The cuff was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When measuring the cuff, the percentage for the symmetry was 40 percent.This result is over 33.3 percent that is the minimum acceptable.Based on the test, sample is within spec.There is no root cause since the complaint was not confirmed.No corrective actions are required since the complaint was not confirmed.Dhr (device history review) review did not indicate any abnormal results.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147., corrected data: b1, h1, d1, d2.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 9960352
• Report Number: 3012307300-2020-02983
• Device Sequence Number: 3354814
• 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: 03/27/2024
• Device Model Number: 67PFS55
• Device Catalogue Number: 67PFS55
• Device Lot Number: 3835797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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): Yes
• 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