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

Model Number 67SP045

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Device evaluation is in progress.

Event Description

It was reported that the cuff component had inflated asymmetrically.The trach tube was removed and replaced with a back up trach as a result.No patient injury or complications were reported in relation to this event.

Event Description

Investigation results completed on a smiths medical silicone - bivona tubes neo/ped tts.This will be summarized in h -10.

Manufacturer Narrative

Investigation results completed on a smiths medical silicone-bivona tube neo/ped tts.Pictures were received along with four samples from p/n (b)(6) l/n unknown.Revealed in pictures the cuff was not inflated fully on one side.When testing device it was visually inspected at 12 inches.Contamination was noted on the cuff.Initially partially inflated but after manipulation the cuff inflated four times uniformly.Prior to release the device passed 100% of testing done by engineering.Unable to establish root cause of event and no fault found.As preventative measures, production personnel was notified by quality engineer on (b)(6) 2020.As awareness of the defect reported by the customer.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9656102
• MDR Text Key: 177554002
• Report Number: 3012307300-2020-00283
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312000733
• UDI-Public: 15021312000733
• Combination Product (y/n): N
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 67SP045
• Device Catalogue Number: 67SP045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1