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

Model Number	67PFSS50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hypoventilation (1916)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device was in use with patient.The reporter stated the device flange tore and required a new tube be placed.No further adverse effects reported.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|silicone: bivona tube flange was confirmed.Product p/n 67pfss50 l/n 3959321 without its original packaging, in used conditions and with its certificate of decontamination was reviewed.The visual inspection revealed split in the flange.Instruction on section 4.8 states: guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.We recommend using the twill tape holder supplied with the product.Engineering production performed and reviewed that 100% tested prior to releasing the manufacture site.
Event or Problem Description
Investigation completed and summarized in h10.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10908249
• Report Number: 3012307300-2020-11784
• Device Sequence Number: 3084255
• Product Code: JOH
• UDI-Device Identifier: 10351688518712
• UDI-Public: 10351688518712
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 01/05/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 67PFSS50
• Device Catalogue Number: 67PFSS50
• Device Lot Number: 3959321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/06/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 30