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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A

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B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A Back to Search Results
Model Number SL-2000M2095
Device Problem Material Puncture/Hole (1504)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/24/2023
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: event 8: hemodialysis description of the patient event venous line started getting air.When looking at the bloodline a small slit was noted in the pump segment.Blood returned to patient and new setup done.Estimated blood loss 10cc.No injury reported.
 
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Brand Name
HEMODIALYSIS BLOODLINES
Type of Device
SET, TUBING, BLOOD, WITH A
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 12th avenue
bethlehem PA 18018 0027
Manufacturer (Section G)
B. BRAUN MEDICAL INC.
824 12th avenue
bethlehem PA 18018 0027
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key16724803
MDR Text Key313139183
Report Number2521402-2023-00093
Device Sequence Number1
Product Code FJK
UDI-Device Identifier04046964367762
UDI-Public(01)04046964367762
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/12/2023
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 NumberSL-2000M2095
Device Catalogue NumberSL-2000M2095
Device Lot NumberA2200814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2023
Initial Date FDA Received04/12/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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