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

Model Number	CUSTOM 4.0 FLEXTEND TTS NS +1/EA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Laceration(s) (1946); Respiratory Distress (2045); Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that smiths bivona® adult tts¿ tracheostomy tracheostomy|silicone - bivona tubes neo/ped flextend plus a child managed to pull out a wire on the trach tube causing the tube to split and emergent trach change out.Reported the child hurt a finger when this incident occurred.Photos show damage.Trach change out resolved issue.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy tube was returned for investigation in used condition.Visual inspection was performed at 12 inches and under normal conditions of illumination so as to look for any damages to the parts.The visual inspection revealed that the shaft was broken and that the wire was exposed.There was also a hole in the adhesive that was attached to the connector.The investigator also examined photographs submitted by the customer.In the first picture, a cut was clearly visible in the middle of the tube.In the second picture, the broken connector and an exposed wire were visible.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The above product problems most likely occurred after the device left the manufacturing facility.A definitive root cause was not established however.

• Brand Name: BIVONA ADULT TTS TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9887056
• Report Number: 3012307300-2020-02259
• Device Sequence Number: 16973785
• Product Code: JOH
• UDI-Device Identifier: 15021312516821
• UDI-Public: 15021312516821
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CUSTOM 4.0 FLEXTEND TTS NS +1/EA
• Device Catalogue Number: 60PFP60
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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