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

Model Number	XU21DS60NSC940N
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for investigation.The returned sample was confirmed to have a cut on the shaft between the connector and the neck flange.It appears to have been caused by a sharp blade/edge given the fact it is a relatively smooth cut (rather than a jagged tear).It cannot be concluded exactly how or when this cut was caused.That said, given that all parts are subject to a 100 percent inspection and the fact that the cut extends through a significant portion of the tube, it is unlikely to have been present prior to the device being packaged and shipped (for if it was present, it would very likely have been detected by the 100 percent product inspection, or the subsequent post-packaging inspection each part is subject to).The dhr was reviewed and found no discrepancies that would cause the reported issue.
Event or Problem Description
It was reported that after opening the package, the plastic sheath around the wire was found torn.No patient injury was reported.

• Brand Name: BIVONA SILICONE TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13561012
• Report Number: 3012307300-2022-03666
• Device Sequence Number: 17221761
• Product Code: JOH
• UDI-Device Identifier: 15019517265224
• UDI-Public: 15019517265224
• 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
• Report Date (Section B): 02/18/2022

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: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: XU21DS60NSC940N
• Device Catalogue Number: XU21DS60NSC940N
• Device Lot Number: ST004368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown