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

Model Number	ZT20AN65NSZ082N
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic piece inside the pilot balloon got pushed into the pilot balloon.No patient injury was reported.
Additional Manufacturer Narrative
Visual inspection of the returned device confirmed that the inflation valve was inside the airway balloon.The airway balloon was visually inspected: no cuts, voids, or molding defects were present in the opening of the balloon that would cause the inflation valve from not remaining in position.After reseating the inflation valve, the device was functionally tested using air.The cuff inflated but immediately deflated.The device was leak tested per work instruction.A cut was identified on the airway balloon.The cut was in the location where the inflation valve had been pushed into the device.Custom devices are 200 percent inspected for leaks and cuff symmetry which requires the inflation valve to be seated properly before packaging.The inflation valve is a press fit into the airway balloon.Since there were no manufacturing defects detected with the inflation balloon or valve, it is likely that extreme force or a twisting motion was used when inserting the syringe to the valve.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record (dhr).This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; zufahrt uber moosfeldstrabe; minneapolis, MN 55442
• MDR Report Key: 15417093
• Report Number: 3012307300-2022-19072
• Device Sequence Number: 11401954
• Product Code: JOH
• UDI-Device Identifier: 15019517218329
• UDI-Public: 15019517218329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: ZT20AN65NSZ082N
• Device Catalogue Number: ZT20AN65NSZ082N
• Device Lot Number: BS003890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown