MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/899/080CZ
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the complaint was limited because no sample was returned.Similar customer complaints where the same issues related to uniperc flange locking mechanism were raised in past and therefore (b)(4) was raised.
Event or Problem Description
It was reported that the latch to unlock the removable collar on this product opened overnight while the patient was sleeping, dislodging the length and making the tube mobile in the patient's trachea.The latch allowing this locking/unlocking of the collar is considered too soft by the customer.The patient would have been admitted to the emergency room.
Additional Manufacturer Narrative
The investigation of the complaint was limited because no sample was returned.Similar customer complaints where the same issues related to uniperc flange locking mechanism were raised in past and therefore (b)(4) was raised.
Event or Problem Description
It was reported that the latch to unlock the removable collar on this product opened overnight while the patient was sleeping, dislodging the length and making the tube mobile in the patient's trachea.The latch allowing this locking/unlocking of the collar is considered too soft by the customer.The patient would have been admitted to the emergency room.

• Brand Name: PORTEX TUBES PDT UNIPERC
• 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: 13361065
• Report Number: 3012307300-2022-01802
• Device Sequence Number: 11181302
• Product Code: BTO
• UDI-Device Identifier: 15019315107238
• UDI-Public: 15019315107238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 100/899/080CZ
• Device Catalogue Number: 100/899/080CZ
• Was Device Available for Evaluation?: No
• 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: 04/28/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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