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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 470100
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/06/2021
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 during disconnecting the set leaked.
 
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Brand NameCARESITE
Type of DeviceSET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
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 18109
4847197287
MDR Report Key12530985
MDR Text Key273317876
Report Number2523676-2021-00322
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 09/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470100
Device Catalogue Number470100
Device Lot Number0061771169
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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