MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED FLEXTEND PLUS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60PFSS45
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was received for evaluation.Visual inspection was performed at 12 inch under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.Results: during the visual inspection, we observed that products inside the trays do not match the labelling.The complaint is confirmed.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.Root cause: investigation and corrective and preventative action has been opened to address the reported issue.This mdr was generated under protocol (b)(4).This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the device was labelled as straight flange but product was a v flange.No patient injury was reported.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND PLUS
• 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: 15280308
• Report Number: 3012307300-2022-15962
• Device Sequence Number: 7139318
• Product Code: JOH
• UDI-Device Identifier: 15021312516791
• UDI-Public: 15021312516791
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/27/2025
• Device Model Number: 60PFSS45
• Device Catalogue Number: 60PFSS45
• Device Lot Number: 3991195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0726-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown