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

Catalog Number	60PFS40
Medical Device Problem Codes	Decrease in Suction (1146); Suction Problem (2170); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem Description
Information was received stating the device was a size 8.
Additional 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
• 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: 8903740
• Report Number: 3012307300-2019-04074
• Device Sequence Number: 18895477
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2019

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 10/23/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/19/2019; 11/21/2019
• 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: 20 MO
• Patient Weight: 9