MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	67PFS35
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: foreign country: (b)(6).
Event or Problem Description
Information was received that while changing the cannula, on a smiths medical bivona flextend tts pediatric straight neck flange tracheostomy tube the cuff inflated asymmetrically causing leakage during mechanical ventilation.A tube change out was required and relieved child of reported discomfort and anxiety.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: additional information d10, h3, h6 device evaluation: a sample was returned for investigation.No damage was identified during the visual inspection.Functional testing was performed.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.The reported failure was not confirmed.The root cause cannot be established.No action taken was taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol b10009406, as a result of warning letter (b)(4).
Additional Manufacturer Narrative
Other, other text: additional information d10, h3, h6 device evaluation: a sample was returned for investigation.No damage was identified during the visual inspection.Functional testing was performed.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.The reported failure was not confirmed.The root cause cannot be established.No action taken was taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9742486
• Report Number: 3012307300-2020-01412
• Device Sequence Number: 1974749
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2022

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: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: 67PFS35
• Device Catalogue Number: 67PFSS35
• Device Lot Number: 3760475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 07/14/2022; 07/14/2022
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 09/15/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 MO
• Patient Sex: Unknown