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

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 05/19/2021

Event Type  malfunction  

Event Description

Patient induction began, providers went to manually ventilate patient and experienced a leak in the ventilator system.A cracked collar on the anesthesia breathing bag was discovered.Anesthesiologist switched the anesthesia machine to vent mode and two hand ventilated the patient with vent assist.Patient was then intubated without incident.Normally patient is induced, manual ventilation until muscle relaxant sets in and then intubation is conducted.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: 11874611
• MDR Text Key: 252693685
• Report Number: MW5101508
• 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: 53 YR