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

Catalog Number	XU18CS40NGE985N
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Laceration(s) (1946); Blood Loss (2597)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal end of a portex® bivona® custom tracheostomy tube bulged, and wire came out of the tube.The product fault was discovered upon removal of the tracheostomy tube.The tube cut and lacerated the patient's stoma.The patient's mother stopped the bleeding with gauze, and suctioned to maintain the airway.No permanent injury was reported.
Additional Manufacturer Narrative
One smiths medical portex® bivona® custom tracheostomy tube was returned for analysis in used condition.Upon visual exam of the tracheostomy (trach) a bulge (coil) of wire noted.However, the wire did not appear to have actually punctured the outer covering of the tube.The part was reviewed with the manufacturing floor supervisor, who confirmed that the routine manufacturing process does not contain any steps that she believed could cause that "bulge." inspection is performed on all parts (100%), which should have detected the observed issue prior to shipment.Pictures were taken and then reviewed by quality and clinical from legal at the manufacturer site.Based on the evidence, it is hypothesized that since the hyper flex option is typically selected for atypical anatomies due to its increased flexibility, it is possible that one of the coils became inadvertently dislodged while the obturator was being removed from the tube which may have been in the "perfect storm" of positions based on patient anatomy.The root cause of the complaint is unknown at this time.

• Brand Name: PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7477496
• Report Number: 3012307300-2018-01256
• Device Sequence Number: 1717786
• Product Code: JOH
• UDI-Device Identifier: 15019517143171
• UDI-Public: 15019517143171
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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: No Information
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: XU18CS40NGE985N
• Device Lot Number: SS013623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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: 6 YR
• Patient Weight: 19