MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60SN035
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3: month and year of event have been provided, day is unknown.D4: lot number, expiration date and h4: device manufacture date 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 during patient use, the printing on the flange was reversed.Adverse patient effects are unknown.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: (b)(6).One device sample was received without the original packaging.Three photos were also received for evaluation; photos showed the complaint sample.Per visual inspection, it can be identified that the printing on the tab is reversed.The complaint was confirmed.The root cause of the reverse tab printing was that the operator did not correctly place the flange in the printing fixture during manufacturing.A device history record (dhr) review could not be performed as the lot number was unknown.This type of defect does not affect the function or functionality of the device, that is, there will be no failure during its use.As an immediate action, the tab printing process was reviewed, and the method is being followed correctly, therefore corrective actions are not necessary.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 17785272
• Report Number: 3012307300-2023-09150
• Device Sequence Number: 15090887
• Product Code: BTO
• UDI-Device Identifier: 15021312000139
• UDI-Public: 15021312000139
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: Health Professional
• Device Catalogue Number: 60SN035
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/04/2023
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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