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

Model Number	SU18KN45NGF993N
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the side of a smiths medical portex bivona tracheostomy tube was noted to be twisted to one side.There were no reported adverse effects.
Event or Problem Description
Information was received that the device was changed out to resolve the incident.
Additional Manufacturer Narrative
B1, b5: additional information.One tracheostomy tube was returned for evaluation.Visual inpsection of the device confirmed the shaft is off center.After closely analyzing the trach, we have determined that an uneven cut at the proximal end of the shaft has caused this tube to sit crookedly.The reported customer complaint has been confirmed, and the problem source has been determined to be manufacturing.

• Brand Name: PORTEX BIVONA TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 10025002
• Report Number: 3012307300-2020-03693
• Device Sequence Number: 3116535
• Product Code: JOH
• UDI-Device Identifier: 15019517170795
• UDI-Public: 15019517170795
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: SU18KN45NGF993N
• Device Catalogue Number: SU18KN45NGF993N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 9