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

Catalog Number	XA19FS60NSA198N
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One customized aire cuff hyperflex device was returned for analysis in used condition.A visual inspection of the product revealed that a section of the shaft near the flange was torn.By device appearance it had undergone excessive tensile force across the proximal length of shaft while connected to ventilator.Based on the evidence the complaint was confirmed but the root cause is unknown.
Event or Problem Description
Information was received indicating that a wire was observed to be poking through the silicone portion of a smiths medical portex bivona flextend¿ tracheostomy tube.A trach tube change out was performed to resolve the issue.There were no reported adverse patient effects.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TRACHEOSTOMY 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: 9188084
• Report Number: 3012307300-2019-05684
• Device Sequence Number: 17114956
• Product Code: JOH
• UDI-Device Identifier: 15019517197082
• UDI-Public: 15019517197082
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2024
• Device Catalogue Number: XA19FS60NSA198N
• Device Lot Number: DS031134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: 14 YR
• Patient Weight: 34