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

Model Number	HT15CS80NSC214N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona custom tracheostomy tube was reported to not be inflating properly.It was reported that the patient was ventilator dependent.Subsequently, a trach tube change out was performed.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy tube was returned for evaluation.Device underwent functional testing, finding a portion of the cuff stuck to the shaft.However, upon following the instructions in the ifu, the cuff was able to inflate.The investigation of the returned device did not identify any manufacturing defects.The reported customer complaint has been confirmed, and no fault found has been identified as the problem source.

• Brand Name: PORTEX BIVONA CUSTOM TRACHEOSTOMY 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: 10511267
• Report Number: 3012307300-2020-09169
• Device Sequence Number: 2572010
• Product Code: JOH
• UDI-Device Identifier: 10351688840899
• UDI-Public: 10351688840899
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: HT15CS80NSC214N
• Device Catalogue Number: HT15CS80NSC214N
• Device Lot Number: BS005367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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