MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	FT22FN40NSE998N
Medical Device Problem Codes	Disconnection (1171); Fracture (1260)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via an email from a customer, that while in patient use, the swivel connector broke away from the proximal shaft of the tracheostomy tube, and it lodged into the elbow of a suction ballard.The product did not cause any patient harm.The trach tube had to be prematurely switched out.The affected trach was swapped with another equivalent bivona.
Additional Manufacturer Narrative
Other text: no lot number was provided; therefore, device history record review could not be performed.A product sample and four (4) photos were received for evaluation.Visual and functional testing were performed.Visual inspection of the device sample found no evidence of manufacturing damage to the trach connector end or the detached swivel connector.Functional testing found the detached swivel connector was gently reattached to the device without difficulty.Device passed all functional testing, unable to replicate the reported issue.Based on device analysis, the complaint cannot be confirmed as a manufacturing nonconformance, but is highly probable to have been caused by a variation in user technique.Corrected data: type of event (b1).

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14990253
• Report Number: 3012307300-2022-13277
• Device Sequence Number: 1562815
• Product Code: JOH
• UDI-Device Identifier: 15019517306545
• UDI-Public: 15019517306545
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Model Number: FT22FN40NSE998N
• Device Catalogue Number: FT22FN40NSE998N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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