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

Catalog Number	67HA80
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during a submission of a tender in denmark, the included instructions for use (ifu) was incomplete and the danish translation was missing.Additionally the translation of the product name contained a typo on the label (reads silicone trakeostomi tube, correct is silicone trakeostomi tube)".
Additional Manufacturer Narrative
Other text: b3: date of event is unknown; no information has been provided to date.D3, g1, and g2 email is: (b)(6).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: h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.No product was returned.The customer provided photos were used for the investigation.The investigation confirmed that the danish translation was missing from the instruction for use (ifu).Review of the pre-printed tray lid and the unitary carton confirmed that "silk one tracheostomitude" had a "d" and not a "b" that was printed for the danish translation.The root cause was attributed to labeling team, quality control, and supplier.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The labeling team was informed about the potential misspelling of tracheostomy tube and will review the concern with the translation house so that it may be included in the next labeling project.The issue has been escalated to determine potential corrective actions for the missing translation on the ifu.

• Brand Name: BIVONA TUBES ADULT HYPERFLEX TTS
• 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: reed covert
• MDR Report Key: 18241963
• Report Number: 3012307300-2023-10902
• Device Sequence Number: 6600584
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: 67HA80
• Device Lot Number: 4362656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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