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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-2010M2096A
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample and one (1) photo were provided by facility for evaluation.The sample was visually evaluated, and it was noted the slim filter was missing from the venous line.Based on the evaluation results, the reported defect was confirmed.Incidents of this nature are attributed to operator oversight during the assembly of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.As a result of this occurrence, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product.The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection processes.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.
 
Event Description
As reported by the user facility/medwatch number mw (b)(4): it was reported that the line set is missing the chamber filter.This has potential for a blood clot to be pumped back into the patient's blood stream.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.
901 marcon blvd.
allentown PA 18109
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 Key15322883
MDR Text Key305412596
Report Number2523676-2022-00443
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 Other,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2022
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 Number00VL822811
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/01/2022
Initial Date FDA Received08/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2022
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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