MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ANESTHESIA BREATHING BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

Anesthesia breathing circuit bag broke on induction (b)(6) 2021.Medication was given to the patient and induction was started.Positive pressure was given through the anesthesia machine.Approx 2-3 breathes were given and the provider heard a leak coming from the anesthesia machine.Physician decided to intubate the patient at this point.Typically they would have continued to mask ventilate the patient until the muscle relaxation meds finished setting in and then intubated the patient in a controlled situation.Fda safety report id# (b)(4).

• Brand Name: ANESTHESIA BREATHING BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 11874633
• MDR Text Key: 252692795
• Report Number: MW5101509
• Device Sequence Number: 1
• Product Code: CAI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR