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

Model Number	FT15GN55NSC248N
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical portex bivona custom tracheostomy (trach) tube had split.Subsequently, a trach tube change out was performed.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Other, other text: one tracheostomy tube was returned for evaluation.Visual inspection of the device found the inflation balloon was missing.Using a syringe with a needle tip, air was inserted into the inflation line.The cuff inflated without difficulties and remained inflated-no defects were identified with the cuff.The end of the inflation line that was missing the balloon was inspected, and the end was noted to be smooth like it had been cut with a sharp object.The device was missing the 8 mm that is secured inside the balloon, which indicates that the inflation line was cut and not the result of a manufacturing fault.The problem source to the confirmed customer complaint has been determined to be user interface.

• Brand Name: PORTEX BIVONA CUSTOM TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10332422
• Report Number: 3012307300-2020-07594
• Device Sequence Number: 17037816
• Product Code: JOH
• UDI-Device Identifier: 15019517012378
• UDI-Public: 15019517012378
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: No Information
• Device Model Number: FT15GN55NSC248N
• Device Catalogue Number: FT15GN55NSC248N
• Device Lot Number: BS000384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/07/2020
• 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