MAUDE Adverse Event Report: DRAGER/DRAEGERWERK AG & CO. KGAA ANESTHESIA CIRCUIT FLEXIBLE TUBING; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number MP02744

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

Event Date 08/02/2023

Event Type  Injury  

Event Description

Description of the problem: anesthesia circuit tubing was found to have a significantly sized hole in it.This was brand new tubing placed just prior to the surgical case.The anesthesia provider discovered this hole after anesthesia induction and lma was placed, after troubleshooting other causes of failure to the circuit.Finding a hole like this is a significant issue not conducive to sustaining a patients life while under general anesthetic.Once hole was discovered, the anesthesia tech immediately changed the tubing and anesthesia was able to maintain the patients airway and proceed with the surgical procedure.

• Brand Name: ANESTHESIA CIRCUIT FLEXIBLE TUBING
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): DRAGER/DRAEGERWERK AG & CO. KGAA
• MDR Report Key: 17811020
• MDR Text Key: 324275737
• Report Number: MW5146122
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP02744
• Device Lot Number: 6356.2903
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male