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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
Catalog Number SL-2000M2095L
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/06/2023
Event Type  malfunction  
Event Description
As reported by the user facility: event 1: detailed inquiry description: during dialysis treatment the streamline bloodline venous pod ruptured forcing blood through pod and into internal transducer of the machine.Upon termination of treatment and removal of lines a large amount of pressure caused blood to spill out onto the external portion of the machine.This happened twice on two different machines.No injury reported.
 
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.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 1.No sample was provided for further evaluation.An approved project is in place to further address issues with leakage.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
 
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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
bethelehem PA 18018
Manufacturer (Section G)
B. BRAUN MEDICAL INC.
824 12th avenue
bethelehem PA 18018
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key17486680
MDR Text Key320763587
Report Number2521402-2023-00220
Device Sequence Number1
Product Code FJK
UDI-Device Identifier04046955348909
UDI-Public(01)04046955348909
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,Followup
Report Date 12/19/2023
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 Catalogue NumberSL-2000M2095L
Device Lot NumberA2200647
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/13/2023
Initial Date FDA Received08/09/2023
Supplement Dates Manufacturer Received07/13/2023
Supplement Dates FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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