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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. ANESTHESIA BREATHING BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
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).
 
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Brand NameANESTHESIA BREATHING BAG
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
MDR Report Key11874633
MDR Text Key252692795
Report NumberMW5101509
Device Sequence Number1
Product Code CAI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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