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

Model Number	60PFPS40
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product samples were received for evaluation.Sample 1 was in new condition in its original packaging.Sample 2 was in used condition without its original packaging.A photograph of the original labeling for sample 2 was also received.A visual inspection was performed.It was observed that the box label and lid label matched for sample 1.The unit inside the tray was inspected and it was confirmed that the unit matched printed information on the label.No discrepancies were found.Sample 2 was measured with a calibrated ruler and it was confirmed that the length was within specification.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.The root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause is that a unit was found without identification and placed with material with the incorrect lot number.Actions were taken to mitigate the reported issue: the relevant procedure was updated to include a message at the beginning of the procedure instructing to scrap any material found without identification.A service request was generated in order to avoid handling material without identification in the area and the personnel was trained.
Event or Problem Description
It was reported that on the outside of the box, the lot number indicates the flange should be straight.When the trach was opened, it was noted that the flange was v-shaped instead.No patient injury was reported.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15698355
• Report Number: 3012307300-2022-26494
• Device Sequence Number: 8228826
• Product Code: JOH
• UDI-Device Identifier: 15021312516838
• UDI-Public: 15021312516838
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: Lay User/Patient
• Device Expiration Date: 01/09/2024
• Device Model Number: 60PFPS40
• Device Catalogue Number: 60PFPS40
• Device Lot Number: 3741727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown