MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY; TUBE, TRACHEOSTOMY

Model Number	FT16HN60NSC963N
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical bivona customer flextend tts tracheostomy tube 19-sep-2019 mdr=yes.It was reported that the tracheostomy tube showed signs of mold.No patient death or serious injury.The complaint device is considered to be a life-supporting or life-sustaining device and thus is essential to maintaining human life as defined in section 519(f) of the fdc act.This file is considered malfunction reportable at this time.Sj.
Event or Problem Description
Additional information was received that a tracheostomy (trach) change out was required.
Additional Manufacturer Narrative
Additional information was received that a tube change out was required.The file has been updated accordingly to reflect the reported serious injury.Possible event date either 01sep19 or 13sep19.
Additional Manufacturer Narrative
Other text: no lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# 617147.G5 is unknown.No product information has been provided to date.
Event or Problem Description
It was reported the device trach has mold.No patient injury reported.

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9160400
• Report Number: 3012307300-2019-05226
• Device Sequence Number: 2449395
• Product Code: JOH
• UDI-Device Identifier: 15019517068085
• UDI-Public: 15019517068085
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2022

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: 05/09/2024
• Device Model Number: FT16HN60NSC963N
• Device Catalogue Number: FT16HN60NSC963N
• Device Lot Number: SS021697
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 09/28/2022
• Initial Report FDA Received Date: 10/06/2019
• Supplement Report FDA Received Date: 10/15/2019; 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: 14 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: White