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

Catalog Number	ZZ19KN70ZZZ006N
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pilot-balloon came lose during trach-change.The red pilot-ballon came loose during uncuffing for cannula replacement."the surface of the end of inflation line is slippery and the super slick is not removed in the adhesive area.There are remains of glue on/in the pilot balloon.¿ adverse patient effects are unknown.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Date of event is unknown; no information has been provided to date.Not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
The following field was updated with corrections: d4.Primary udi number: (b)(4).D9.Date returned to mfg: 23-may-2024.H6.Investigation codes: updated.Investigation summary: received one custom 7.0 uncuffed standard shaft, 45-degree neck flange and a stoma foam cuff with the red plug not attached to the airway line.Decontaminated per internal procedures.Visual inspection by the unaided eye under normal plant lighting of the red plug revealed adhesive at the opening where the airway line was inserted.Visual inspection by the unaided eye under normal plant lighting of the airway line revealed evidence of adhesive and a small trace of red silicone from the red plug.The drawing states to mask the airway line prior to superslick.A tactile inspection was performed of the airway line.It was confirmed that the airway line had been masked prior to superslick, which allowed for the adhesive to bond the plug to the airway line.This was also evident by the small red silicone remnants that remained on the airway.The red plug was cut open and revealed trace amounts of adhesive.No manufacturing defect was detected.The plug likely became caught on something which tore the plug from the airway line.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19355178
• Report Number: 3012307300-2024-03964
• Device Sequence Number: 7703132
• Product Code: JOH
• UDI-Device Identifier: 15019517209983
• UDI-Public: (01)15019517209983(17)290111(10)GB014929
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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 Catalogue Number: ZZ19KN70ZZZ006N
• Device Lot Number: GB014929
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown