MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX T; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	75FHXL70
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is excess plastic on the inside of the tubing.There was no adverse event or injury.
Additional Manufacturer Narrative
Other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.There were no non-conforming reports (ncrs) initiated for the lot, or anomalies identified in the dhr (device history review).A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: e4: correction: customer reported to fda: no information.

• Brand Name: BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX T
• 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; 3400 ministry pkwy; minneapolis, MN 55442
• MDR Report Key: 15184165
• Report Number: 3012307300-2022-14933
• Device Sequence Number: 17739849
• Product Code: JOH
• UDI-Device Identifier: 15021312015683
• UDI-Public: 15021312015683
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 04/09/2026
• Device Model Number: 75FHXL70
• Device Catalogue Number: 75FHXL70
• Device Lot Number: 4128074
• Was Device Available for Evaluation?: No
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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
• Patient Sex: Unknown