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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 Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2023
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: detailed inquiry description: venous pressure stops registering, doesn't hold the appropriate pressure, small air leak.No injury reported.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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 Key17149398
MDR Text Key317671572
Report Number2521402-2023-00180
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,Followup
Report Date 02/12/2024
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 NumberA2200514
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/26/2023
Initial Date FDA Received06/18/2023
Supplement Dates Manufacturer Received05/26/2023
Supplement Dates FDA Received02/12/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/07/2022
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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