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

Model Number 100/899/080CZ

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 285634471
• Report Number: 3012307300-2022-01802
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107238
• UDI-Public: 15019315107238
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1