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

Model Number	CMZ2050S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned.The angle of the shaft was determined to be greater than the requested tolerance.A special fixture was developed to aid in reducing the variation.Once samples are confirmed to be acceptable to the end user, the prototype fixture will be finalized.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record.
Event or Problem Description
It was reported that four tracheal tubes were out of specification.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: update not required h10: device evaluation was completed.The results were filed with the initial mdr.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: b5: additional information.H6: event problem and evaluation codes: updated.H10: device evaluation was completed.The results were filed with the initial mdr.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: h6: correction: event problem patient code: 1994-pain c3303.
Event or Problem Description
Additional information was received on 12-nov-2022 via email and attached to complaint object: updated date of event: (b)(6) 2021; the event occur while the device was in use with a patient; the product issue caused or contributed to patient or clinical injury; patient details updated.Item was removed after the patient complained "it hurt inside".The patient did not receive any medical treatment or any additional intervention.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15392635
• Report Number: 3012307300-2022-18312
• Device Sequence Number: 17395118
• Product Code: JOH
• UDI-Device Identifier: 15019517200942
• UDI-Public: 15019517200942
• Combination Product (Y/N): N
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/04/2026
• Device Model Number: CMZ2050S
• Device Catalogue Number: CMZ2050S
• Device Lot Number: GA015339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 12/15/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/19/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female