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

Catalog Number	60A170
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.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.
Event or Problem Description
It was reported that the included instructions for use (ifu) is incomplete.The danish translation was missing.Additionally the translation of the product name contained a typo on the label.Label reported to have read "siliconetrakeostomitude".Correct is "siliconetrakeostomitube".Photos show unopened product boxes.No patient involvement or adverse effects reported.
Additional Manufacturer Narrative
Device evaluation: the investigation confirmed that the pre-printed unitary carton (10018910-001) states silikonetrakeostomitude for the danish translation.The pre-printed tyvek lid (10018917-001) does not contain any product translations except for english (per designed).The variable label ((b)(4)) does not contain any product translations except for english (per designed).The instruction for use (10018855-001) states bivona trakeostomitube uden cuff til voksne.The ifu contains the required "b" which is considered correct by the complainant.The only labelling item confirmed to be spelled with a "d" is the pre-printed unitary carton.The complaint was confirmed.The complaint information was communicated to the labeling team so the spelling printed on the unitary carton can be verified by the translation vendor during the rebranding project.Email is: regulatory.Responses@icumed.Com.

• Brand Name: BIVONA ADULT CUFFLESS TRACHEOSTOMY
• 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: 18234396
• Report Number: 3012307300-2023-10853
• Device Sequence Number: 6936566
• Product Code: JOH
• UDI-Device Identifier: 15021312005561
• UDI-Public: 15021312005561
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083641
• 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): 02/23/2024

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: 60A170
• Device Lot Number: 4381787
• 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: 01/02/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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