MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX UNIPERC ADJUSTABLE FLANGE EXTENDED-LENGTH; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/897/070CZ
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product is not sealed and sterile upon opening.On one, the joint to the white paper on the inner packaging was loose, and open to the products.No patient involvement.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source is unknown.Based on strong detection mechanism in place it is highly improbable that product left smiths medical (b)(4) manufacturing site in such conditions.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE EXTENDED-LENGTH
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14437536
• Report Number: 3012307300-2022-09126
• Device Sequence Number: 14927067
• Product Code: BTO
• UDI-Device Identifier: 15019315107191
• UDI-Public: 15019315107191
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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 Expiration Date: 10/20/2025
• Device Model Number: 100/897/070CZ
• Device Catalogue Number: 100/897/070CZ
• Device Lot Number: 4043347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown