MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE

Model Number	100/136/070
Medical Device Problem Codes	Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when passing a stylet through the endotracheal tube upon the use of it, the stylet pierced the tube at the part where it was bent at an acute angle.The customer requested us to identify whether there was any anomaly in the endotracheal tube.No patient injury.
Additional Manufacturer Narrative
Other text: investigation results completed on a smiths medical ntubation|portex endotracheal tubes polar.Four photos attached and in photo three the complaint was confirmed.Sample from p/n (b)(6) revealed a hole in the tube.No other analysis and the complaint was confirmed.Root cause may be related to clinical methods performed.
Event or Problem Description
Investigation completed and summary in h 10.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11478456
• Report Number: 3012307300-2021-02043
• Device Sequence Number: 11668804
• Product Code: BTR
• UDI-Device Identifier: 15019315021312
• UDI-Public: 15019315021312
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: No Information
• Device Expiration Date: 03/26/2025
• Device Model Number: 100/136/070
• Device Catalogue Number: 100/136/070
• Device Lot Number: 3952573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/04/2021
• Initial Report FDA Received Date: 03/13/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1