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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
Model Number SL-2010M2096A
Device Problems Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
Patient Problem Hemorrhage/Bleeding (1888)
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 12: "i've been having problems with the streamlines when it's time to return patients.When we connect the arterial line to the saline line, the lines sucks air.You have to either keep screwing it on and off for it not to suck or screw it on really tight.It's like a seal in the saline line that's keep the saline from moving through the lines.No patients were injured as a result, but some blood lost due to clotting from air getting in lines.".
 
Manufacturer Narrative
Event 12: this report has been identified as b.Braun medical internal report number (b)(4).Fourteen (14) unused samples in original packages were returned for evaluation.Samples were visually evaluated, and no defects were observed.All samples were occlusion and leak tested with passing results.In addition, all samples were attached to a water line, and all locksites were tested by pushing and pulling fluid through a syringe, and on all fourteen samples, the fluid freely flows through the line.Based on the evaluation results, the defect was not confirmed.The product met internal specifications.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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 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 Key17083125
MDR Text Key317669563
Report Number2523676-2023-00278
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,Followup
Report Date 07/30/2023
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-2010M2096A
Device Catalogue NumberSL-2010M2096A
Device Lot Number0061847732
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2023
Initial Date FDA Received06/07/2023
Supplement Dates Manufacturer Received05/19/2023
Supplement Dates FDA Received07/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2022
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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