MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY; TUBE, TRACHEOSTOMY

Model Number	65P045
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was found that the inner package was opened when the trach was being taken out of the box.No patient injury reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One (1) picture was received.In picture 1, the original packaging was observed.In picture 2, it was observed that the original tray is open.Also it was observed that the seal for the tray seems completed and uniform according to specifications.One (1) sample was received without its original packaging inside a ziploc bag.Sample was in used conditions.Visual inspection was performed in order to detect any damage on the part.No damage could be detected.No functional testing was required during evaluation.A review of the manufacturing process 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.After a review of the different verifications that are performed during the manufacturing process to verify the seal of the tray, the most probable root cause is that tray was opened after the product left the manufacturing facility.As a preventive action, a notification of this complaint to the production personnel was conducted by the quality engineer for awareness of the reported issue.

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY
• 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; no 678 gubei road; minneapolis, MN 55442
• MDR Report Key: 15635604
• Report Number: 3012307300-2022-25220
• Device Sequence Number: 6373168
• Product Code: JOH
• UDI-Device Identifier: 15021312005981
• UDI-Public: 15021312005981
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/19/2022

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: Health Professional
• Device Model Number: 65P045
• Device Catalogue Number: 65P045
• Device Lot Number: 3489388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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