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

Model Number	67HA80
Medical Device Problem Codes	Component Missing (2306); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a new tracheostomy was found without locking pin and wrong locking tab location.No injury was reported.
Additional Manufacturer Narrative
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
Other text: d10 and h6 conclusion codes: updated.Device evaluation: one device and photographs were submitted for evaluation.Review of the provided pictures and the returned device confirmed a manufacturing issue; it is not possible for the customer to have removed the pin without damaging the neck strap.In addition the hole that is required to be punched through the neck strap that is part of the locking mechanism was absent.Review of the finished good history record showed two different locking strap lots were used for product completion.One of those device lots was rejected.No other complaints have been received for this lot regarding a missing pin and a review of complaints since 2018 did not identify any complaints for a missing pin on adjustable part numbers.The defect has a low risk for patient injury since the missing locking pin would be noticeable prior to use and the instruction for use states under warnings that the device must be thoroughly inspected for signs of damage or wear prior to each use and to not use a tube that is cut or damaged.A review of the manufacturing process determined that the most likely root cause is a missed hole punch during manufacture.A review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16694011
• Report Number: 3012307300-2023-03705
• Device Sequence Number: 12244885
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: 67HA80
• Device Catalogue Number: 67HA80
• Device Lot Number: 4205277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian