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

Catalog Number	FU17FN40NGE093N
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that the cannula was wrong to a smiths medical portex® bivona customized tracheostomy (trach) tube.There were no reported adverse effects.
Additional Manufacturer Narrative
One tracheostomy was returned to evaluate the incorrect cannulas received.The returned devices were reviewed against the template.The devices were built correctly.Customer service determined that the customer who orders the part number is not located in the country where the devices were received.Shipping documents for the identified lot showed that the devices were shipped to the correct customer.Based on the investigation, it is assumed that the devices were placed in the incorrect shipping carton.The customer complaint has been confirmed, and the problem source has been determined to be shipping.

• Brand Name: PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY (TRACH) TUBE
• 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: 8685506
• Report Number: 3012307300-2019-03236
• Device Sequence Number: 2256932
• Product Code: JOH
• UDI-Device Identifier: 15019517110319
• UDI-Public: 15019517110319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/10/2023
• Device Catalogue Number: FU17FN40NGE093N
• Device Lot Number: DS020844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1