MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	100/541/080CZ
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu) malfunctioned.Due to daily use of 1st cannula (picture attached) since february 2021 it is got cracked so we opened a pack of 2nd cannula (picture attached) but while using it we are facing a problem, that while mother coughs it comes out from the tracheostomy kit and it happens regularly.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11962282
• Report Number: 3012307300-2021-05747
• Device Sequence Number: 3692932
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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 Model Number: 100/541/080CZ
• Device Catalogue Number: 100/541/080CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/08/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1