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

Catalog Number	ST19EN55NGG996N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that 24 hours following placement of a smiths medical portex® bivona customized tracheostomy (trach) tube the port is left open to the cuff following filling.It was reported that when the syringe is removed after filling the cuff, the inside white plastic piece comes out, leaving an opening into the patient's cuff.Subsequently, the tube was changed out with no adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device found it to be have markings on the exterior airway tubing.The device underwent leak testing, confirming the reported customer complaint.It was reported the customer "used their teeth" ti stabilize, which led them "biting through the pilot balloon".The customers complaint also alleges an issue where the "inflation line" would keep falling out after filling the cuff with water or removing water from it.The valve of the returned sample (as well as all other components) was reviewed and found to be in the correct position.Upon inflating/deflating the tube, there were no issues noted where anything became separated.Investigation confirmed an inflation issue with the returned sample.It appears to originate from marks on the airway tubing which are likely bite marks based on the customer's correspondence.The directions for use advise to avoid contact with the product from sharp edges.Although it cannot be definitively determined what led to the customer's inflation problem, it is highly likely to be a use issue.

• Brand Name: PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8894634
• Report Number: 3012307300-2019-04188
• Device Sequence Number: 205554
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: ST19EN55NGG996N
• Device Lot Number: SS022168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/29/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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: 12 YR