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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXGUARD; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. MAXGUARD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MA3131
Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2022
Event Type  malfunction  
Event Description
Bd maxguard 10 drop admin set- when this sterile iv tubing is connected to a stopcock, it leaks around the threading even if it is threaded/tightly correctly.This line is connected to a sheath that goes into the left atrium of the heart and could introduce air if the tubing is leaking.We connect this tubing to a bag of fluid under pressure.I cannot include the fluid bag and pressure bag because we switch out the tubing and continue to use the fluid bag under pressure.We always check this connection before the iv tubing is ever connected to the sheath (connected to the patient).This is event number 5 for this same product- please refer to 2022-8109, 2022-8110 and 2022-8112.Manufacturer response for set, administration, intravascular, maxguard (per site reporter).Will obtain.
 
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Brand Name
MAXGUARD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key15949682
MDR Text Key305244904
Report Number15949682
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403235825
UDI-Public(01)10885403235825(10)22069490(17)250623
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/30/2022
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 NumberMA3131
Device Catalogue NumberMA3131
Device Lot Number22069490
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2022
Event Location Hospital
Date Report to Manufacturer12/09/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/09/2022
Type of Device Usage Unknown
Patient Sequence Number1
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