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

Model Number	100/897/080CZ
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and 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 the blue latch that locks the trach tube in place did not work.Trach had to be removed from the patient and a new one opened.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: one (1) used decontaminated sample was received.Under visual inspection, it was observed that the blue locking lever was disassembled from flange body.A non-conformance report was issue for similar customer complaints on the flange locking mechanism.Functional inspection assembled the locking lever back to flange body and can confirm that after assembly, locking mechanism works well.An internal capa was issued; the root cause was attributed to the design of adjustable flange which allows it to unscrew the blue locking lever.This issue is currently monitored via customer a complaint trend.Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a batch related problem.

• Brand Name: UNIPERC ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEO
• 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): NULL; 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: 15293260
• Report Number: 3012307300-2022-16194
• Device Sequence Number: 7139141
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 09/03/2025
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3989238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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