MAUDE Adverse Event Report: NULL PORTEX FLEX TUBING; TUBE, ASPIRATING, BRONCHOSCOPE, RIGID

Model Number 002837

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

No investigation completed due to device not being returned for investigation.

Event Description

It was reported that after induction and draping the patient, the anesthesia reported difficulty maintaining tidal volumes.The extension tubing was changed and then it was later realized there were holes in the gooseneck tubing.Afterwards, the patient's blood pressure dropped and then jumped to over 200 systolic.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10020.The report was submitted in error.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10020.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: PORTEX FLEX TUBING
• Type of Device: TUBE, ASPIRATING, BRONCHOSCOPE, RIGID
• Manufacturer (Section G): NULL
• MDR Report Key: 12642658
• MDR Text Key: 279251061
• Report Number: 3012307300-2021-10020
• Device Sequence Number: 1
• Product Code: KTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 002837
• Device Lot Number: 4144569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 06/02/2023; 06/02/2023
• Supplement Dates FDA Received: 06/05/2023; 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 070022 0000-2021-8066
• Patient Sequence Number: 1