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

Model Number	SU14KN65NSC013S
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Although no lot number was provide, a device history record (dhr) review was conducted on the immediate lot that shipped prior to the initiation of the complaint.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the dhr or in the sterile load documents.No details are available with regard to visual and functional testing methods.Because the mold developed after initial use, the most probable root cause is inadequate cleaning methods.If the trach was not completely dried before being stored per the instructions for use, mold would likely grow.Without information about the cleaning method, storage conditions or the number of re-processing, no definitive conclusions can be made.No corrective actions are planned at this time.The manufacturer regularly analyzes complaint data and trends and will take further actions accordingly.No product information has been provided to date.
Event or Problem Description
It was reported that mold was observed.No patient injury was 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: 15685101
• Report Number: 3012307300-2022-26381
• Device Sequence Number: 6422041
• Product Code: JOH
• UDI-Device Identifier: 10351688846914
• UDI-Public: 10351688846914
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SU14KN65NSC013S
• Device Catalogue Number: SU14KN65NSC013S
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• 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: 09/28/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Race: White