MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES PDT UNIPERC; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 100/897/080CZ

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation in progress.

Event Description

It was reported that the cuff on the tracheostomy tube ruptured.The product problem was observed immediately upon use.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Other, other text: returned device was received in used physical condition.During the evaluation of the device, there was a puncture in the inflation lumen of the tracheostomy.Such a defect can happen only if the adjustable flange is over pulled above the marking on the tube which is in conflict with the instructions for use.This was found to be caused by use error.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX TUBES PDT UNIPERC
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 10949971
• MDR Text Key: 219887578
• Report Number: 3012307300-2020-12120
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3839160
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1