MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT19EN50NSF060N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a brand new trach was taken out of the box.Placed on patient and when caregiver went to secure the trach with trach ties the flange broke.No injury reported and no medical intervention, they used their emergency trach.
Additional Manufacturer Narrative
Event problem and evaluation codes: updated.A finished goods device history record (dhr) review as well as the dhr for the neck flange was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and photo were received for evaluation.Visual inspection found an additional mark / nick in the lower quadrant of the eyelet below the tear.The location of the lower mark / nick is likely where the bottom of the trach holder rested on the eyelet.The root cause of the reported issue was found to be resulted from the device being in contact with a sharp object such as a trach holder that uses velcro or metal clips.The instruction for use states under warnings to guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.Smiths medical recommends using the twill tape holder supplied with the product.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim bradford ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15734641
• Report Number: 3012307300-2022-26751
• Device Sequence Number: 12341362
• Product Code: JOH
• UDI-Device Identifier: 15019517192186
• UDI-Public: 15019517192186
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2023

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: FT19EN50NSF060N
• Device Catalogue Number: FT19EN50NSF060N
• Device Lot Number: GA026447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 04/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Race: White