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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODAN USA, CORP. BODYGUARD MICROSET SET, ADMINISTRATION, INTRAVASCULAR

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CODAN USA, CORP. BODYGUARD MICROSET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number A120-160XSFK
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/27/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020, patient's mother called in after hours to report a break in the tubing above the luer lock connection and that the line had fallen on to the floor. After speaking with the oncology team at (b)(6) medical center, the decision was made to send the patient to (b)(6) where she was re-admitted. (tubing was disposed by (b)(6)). Fda safety report id# (b)(4).
 
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Brand NameBODYGUARD MICROSET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CODAN USA, CORP.
santa ana CA 92704
MDR Report Key10413226
MDR Text Key203298667
Report NumberMW5096087
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA120-160XSFK
Device Lot Number16493
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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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