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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. CARESITE SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 415122
Device Problem Fluid Leak (1250)
Patient Problems Missed Dose (2561); Chemical Exposure (2570)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical internal report number (b)(4). 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: it was reported that a crack was observed on the green portion of the y-extension set. Chemotherapy of cyclophosphamide and blood leaked. No injury reported.
 
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Brand NameCARESITE
Type of DeviceSET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
Manufacturer (Section G)
B. BRAUN DOMINICIAN REPULIC INC.
las americas industrial park
km22 autopista las americas
santo domingo
DR
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, pa 
7197287
MDR Report Key10397395
MDR Text Key202587944
Report Number2523676-2020-00236
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number415122
Device Catalogue Number415122
Device Lot Number0061728333
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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