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

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

Two devices were returned for evaluation.Both were determined to have a torn eyelet upon visual inspection.Tears were in the upper inside corners of each.A damaged eyelet can result in decannulation of the tracheostomy tube.Smiths medical recommends using the twill tape holder supplied with the product.The instruction for use 4.10 guard against product damage by avoiding contact with sharp edges.The reported customer complaint was confirmed.However, no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

Event Description

Information was received that the flange of a smiths medical bivona custom tracheostomy tube had torn.It was found the incorrect tracheostomy tube ties were being used.It was reported that the cotton ties provided in the box are not conducive to the patients care.They tore easily, and were cumbersome to use.A tracheostomy tube change out was required.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8278534
• MDR Text Key: 134119405
• Report Number: 3012307300-2019-00413
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/25/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention