MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVIONA STANDARD HYPERFLEX CUSTOM TRACHEOSTOMY TUBE

Catalog Number CM1812N

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

The customer has not yet returned the device to the manufacturer for evaluation.When the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results.

Event Description

The distributor reported on behalf of the device user stating that the user found the tracheostomy tube leaking at the cuff after approximately 1 week of use.No permanent injury was reported.

Manufacturer Narrative

Suspect device returned for evaluation.Cuff was injected with 15 cc's of air.Cuff remained inflated with no leak detected.Customer reported that the leak occurred near the stoma area.This description suggests that the custom-made tube design may need to be reviewed and modified by the doctor due to changes in the patient anatomy.Investigation determined that the event was not caused by an intrinsic defect in the product.

• Brand Name: BIVIONA STANDARD HYPERFLEX CUSTOM TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5100731
• MDR Text Key: 26639688
• Report Number: 2183502-2015-00700
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/20/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2020
• Device Catalogue Number: CM1812N
• Device Lot Number: GS000879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1