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U.S. Department of Health and Human Services

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

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B. BRAUN DOMINICIAN REPULIC INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A Back to Search Results
Catalog Number SL-2010M2096A
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/06/2024
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 1 : we have found that several of the b.Braun dialog streamlines have pin-size holes in them (in the venous line below the venous chamber), which has resulted in patient blood loss.Additionally, this poses an increased risk of bacterial proliferation to immunocompromised patients with kidney failure.We experienced issues with 4 sets of lines today from lot# 0061904857, exp (b)(6) 2026.
 
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Brand Name
HEMODIALYSIS BLOODLINES
Type of Device
SET, TUBING, BLOOD, WITH A
Manufacturer (Section D)
B. BRAUN DOMINICIAN REPULIC INC.
las americas industrial park
km22 autopista las americas
santo domingo,
DR 
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 Key18921888
MDR Text Key337878618
Report Number2523676-2024-00277
Device Sequence Number1
Product Code FJK
UDI-Device Identifier04046955674992
UDI-Public(01)04046955674992
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2024
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 Catalogue NumberSL-2010M2096A
Device Lot Number0061904857
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2024
Initial Date FDA Received03/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/26/2023
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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