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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE SET, ADMINISTRATION, INTRAVASCULAR

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B. BRAUN MEDICAL INC. CARESITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 470108-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Fever (1858); Sepsis (2067); Septic Shock (2068)
Event Date 12/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device involved has been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
 
Event Description
As reported by the user facility: three days after the valve was inserted into the patient, an infection was observed. Furosemide was infused though the valve from (b)(6) 2020 to (b)(6) 2020. The patient experienced redness local to the insertion site, fever, and sepsis/septic shock. The customer was then treated with an iv antibiotic treatment for five days, and their condition favorably improved rapidly.
 
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Brand NameCARESITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown 18109
Manufacturer (Section G)
B. BRAUN DOMINICAN REPUBLIC, INC.
las americas industrial park
km22 autopista las americas
santo domingo,
DR
Manufacturer Contact
jonathan severino
901 marcon blvd
allentown 18109
MDR Report Key11280427
MDR Text Key230328151
Report Number2523676-2021-00027
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K942988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number470108-01
Device Lot Number0061744004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/04/2021 Patient Sequence Number: 1
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