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

Model Number	670185
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that one day following placement of a smiths medical portex bivona adult tts tracheostomy tube the patient became short of breath and the ventilator alarmed.An emergent tube change out was performed successfully.Following removal of the tube, the cuff was found to be leaking.No further adverse events were reported.
Additional Manufacturer Narrative
One bivona adult tts tracheostomy tube was returned for analysis.Visual inspection revealed that the cuff was slightly discolored.The sample was leak tested; a leak was observed coming from the cuff on the posterior side of the shaft.Under magnification, the leak appeared to be coming from the adjacent side part to the parting line of the molded cuff.Due to the proximity of the cut to the parting line, the investigation could not definitely determine whether the cut resulted from a manufacturing issue or to the part meeting a sharp object.A three-year review of leak testing was performed; no discrepancies noted.Based on the evidence the complaint was confirmed.However, the root cause is unknown.

• Brand Name: BIVONA
• 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: 10075919
• Report Number: 3012307300-2020-04634
• Device Sequence Number: 2783271
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: Health Professional
• Device Model Number: 670185
• Device Catalogue Number: 670185
• Device Lot Number: 3596247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: Life Threatening; Required Intervention