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

Model Number	FT19EN50NSF060N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient became decannulated as the flange of the trach broke and it became unsecured.There was injury, no harm to patient or adverse affects.No no medical intervention was required.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Other text: the complaint sample and a photo was returned for evaluation.Visual inspection was performed with the unaided eye.Inspection of the photo provided by the complainant showed a torn eyelet.Inspection found that the sample had a split on the righthand eyelet in the lower right quadrant and a slight nick / cut started to develop on the upper right quadrant of the eyelet.There appeared to be two small nicks / cuts forming on the lower and upper left side quadrants of the left-hand eyelet.Fault has been confirmed and no other product fault was detected.A pull test was conducted on the left-hand eyelet with the two slight nicks / cuts to determine the eyelet strength; the result of the pull test confirmed that the product meets the required specification for eyelet strength.The eyelet broke at 15.83 lbf (pounds-force) which exceeded the minimum requirement of 11.24 lbf (pounds-force).The split on the eyelet likely resulted from the device being in contact with a sharp object such as a velcro tracheostomy holder.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.Using the twill tape holder supplied with the product is suggested.No corrective actions are planned at this time.Complaint data and trends are regularly analyzed and further actions are taken accordingly.A device history record review was unable to be performed since no lot number was provided.(h6c, h6d, h6e).D4: device lot number is unknown, no product information has been provided to date.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBE, ADULT
• 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 vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15046697
• Report Number: 3012307300-2022-13546
• Device Sequence Number: 12346644
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: Other
• Device Model Number: FT19EN50NSF060N
• Device Catalogue Number: FT19EN50NSF060N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 11/14/2022
• 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
• Patient Age: 12 YR
• Patient Sex: Female