MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60PFS50
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
The surface on a cannula of a smiths medical tracheostomy was reported to be uneven.No adverse effects reported.
Additional Manufacturer Narrative
H3: two samples of bivona tubes neo/ped flextend plus from p/n 60pfs50 l/n 3702475 were received; one in new condition inside its closed original packaging and one in used condition, without its original packaging and with its certificate of safe handling.Visual inspection was performed at 12" under normal conditions of illumination in order to detect any damage on the part.During the visual inspection, it was observed that there was flash at the partition line of the units.Flash was measured using an optical comparator.The result was 0.007", this result is over 0.005" which is the minimum acceptable.Based on the test, the units are out of specification.Relevant documents were reviewed and considered adequate and correct for testing and inspection activities.The reported "uneven cannula surface" was able to be duplicated.The most probable root cause for this issue is that flash from the molding process was not detected during the 100% visual inspection after the cryogenic process and during the assembly process.

• Brand Name: SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9168554
• Report Number: 3012307300-2019-05530
• Device Sequence Number: 2592442
• Product Code: JOH
• UDI-Device Identifier: 15021312005882
• UDI-Public: 15021312005882
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/17/2020

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
• Operator of Device: No Information
• Device Expiration Date: 10/14/2023
• Device Model Number: 60PFS50
• Device Catalogue Number: 60PFS50
• Device Lot Number: 3702475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1