MAUDE Adverse Event Report: ST PAUL PORTEX ENDOTRACHEAL TUBES INTUBATION; TRACHEOSTOMY TUBE

Catalog Number 100/190/050

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported that the valve of a pilot balloon had a crack in it, so the patient had to be re-intubated.No patient injury was reported.

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX ENDOTRACHEAL TUBES INTUBATION
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 13159169
• MDR Text Key: 286500433
• Report Number: 3012307300-2022-00081
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/190/050
• Device Lot Number: 4144617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 04/21/2023; 04/21/2023
• Supplement Dates FDA Received: 02/28/2022; 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention