• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A Back to Search Results
Catalog Number SL-2000M2095L
Device Problem Air/Gas in Device (4062)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/28/2023
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: event 16: detailed inquiry description: difficulty attaching the arterial lines to the saline port.It is hard to firmly attach, pulling in air and then the nurses are unable to return all the blood.It is also difficult to administer meds through this port, it seems they can't get past the seal on the needleless port.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 16: one (1) video was submitted to the manufacturer for evaluation.Through visual examination of the video, it noted that the video depicted a customer applying a syringe on the locksite of the iv line of the artist set and applying force on the plunger with no movement occurring.Verifying all clamps and caps were remove, no fluid was able to pass through the locksite connection.The sample within the video is not within specification; the reported defect is confirmed.While a defect was confirmed, a root cause could not be determined.An approved project is in place to further address issues with lockstie occlusion.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17870536
MDR Text Key324922682
Report Number2521402-2023-00250
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 09/27/2024
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-2000M2095L
Device Lot NumberA2300040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/11/2023
Initial Date FDA Received10/04/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/27/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-