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

Model Number	ST19EN55NGG996N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that leaking occurred four days following placement of a smiths medical portex bivona custom tracheostomy tube.It was reported that the patient requires that the cuff be inflated with sleep for proper ventilation.So, a trach tube change out was performed.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One bivona tracheostomy tube was received for analysis.The part and lot numbers were st19en55ngg996n and ss028781 respectively.After examining the returned tracheostomy tube it was noted that there was a functional failure, but the investigation could not specifically replicate the cuff leakage that the customer described.It is possible that the product terms were used incorrectly.What was found was an inflation defect, neither air nor sterile water could be sufficiently sustained by the cuff because it was escaping from the pilot balloon.Upon further visual inspection it was evident that the pilot balloon had multiple puncture marks.A leak test was performed by adding 5 ccs of air to the device and submerging it in a shallow bath of water.The leak test determined that the punctures on the pilot balloon were deep enough to allow air to escape.From this analysis it was evident that the balloon came into contact with something sharp to inflict this type of perforation.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.It cannot be definitively stated how the damage to the pilot balloon occurred.However, this complaint will be monitored to reveal any trends that may lead to further corrective actions being implemented.

• 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: 10545828
• Report Number: 3012307300-2020-09420
• Device Sequence Number: 3569255
• Product Code: JOH
• UDI-Device Identifier: 15019517190663
• UDI-Public: 15019517190663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 05/05/2025
• Device Model Number: ST19EN55NGG996N
• Device Catalogue Number: ST19EN55NGG996N
• Device Lot Number: SS028781
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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
• Patient Age: 13 YR
• Patient Weight: 53