MAUDE Adverse Event Report: ST PAUL PROTEX; NASAL TRACHEAL TUBE

Model Number 8.0MM

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Hemorrhage, Subgaleal (2603)

Event Type  Injury  

Event Description

Information received a smiths medical intubation|portex airway nasopharyngeal caused bleeding to patient as the customer stated the airway was very rigid.

• Brand Name: PROTEX
• Type of Device: NASAL TRACHEAL TUBE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; college of medicine building; minneapolis, MN 55442
• MDR Report Key: 10979253
• MDR Text Key: 220628411
• Report Number: 3012307300-2020-12240
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8.0MM
• Device Catalogue Number: 100/210/080
• Device Lot Number: 3805432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other