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

Catalog Number 60PFS40

Device Problems Decrease in Suction (1146); Suction Problem (2170); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  Injury  

Event Description

It was reported that the customer was unable to pass the catheter clearly through the tracheostomy tube.The suction catheter appeared to have caught at l1.The tracheostomy tube was changed as a result.No patient injury or further complications were reported in relation to this event.

Event Description

Information was received stating the device was a size 8.

Manufacturer Narrative

One tracheostomy was returned for evaluation.Visual inspection found the device to have black contamination on the obturator and marks were found on the tube.The tube length and obturator protrusion were measured with a calibrated ruler; device met specification for both.During verification, 32 assemblies were taken out of production floor inventory and reviewed to see if they met the specifications accordingly.No discrepencies were found.Quality personnel perform an inspection to verify that the shaft is fully seated to connector, that there is no exposed wire in the shaft, as well as no lack of or excess adhesive.The reported complaint was unable to be confirmed, and the problem source was unalbe to be determined.

• 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: 8903740
• MDR Text Key: 154688825
• Report Number: 3012307300-2019-04074
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (y/n): N
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/13/2022
• Device Catalogue Number: 60PFS40
• Device Lot Number: 3400947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 MO
• Patient Weight: 9