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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC HEMODIALYSIS BLOODLINES; BLOOD TUBING SETS

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B. BRAUN MEDICAL INC HEMODIALYSIS BLOODLINES; BLOOD TUBING SETS Back to Search Results
Model Number SL-2010M2096
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical inc.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 user facility: a bug was found inside the line of the bloodline set.No injuries were reported.
 
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).All information associated with this event was submitted to the bloodline manufacturer.According to the manufacturer investigation, the blood tubing set was returned for evaluation and a picture was also provided.The complaint was confirmed when the set and photograph were visually inspected, finding a bug in the venous line.Additional photographs of the set were taken and provided to manufacturing for review.Manufacturing was unable to determine the root cause of this issue based on the available information.A review of the device history records for sl-2010m2096 from lot 10354010 was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.If additional pertinent information becomes available a follow-up report will be filed.
 
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Brand Name
HEMODIALYSIS BLOODLINES
Type of Device
BLOOD TUBING SETS
Manufacturer (Section D)
B. BRAUN MEDICAL INC
824 12th avenue
bethlehem PA 18018 0027
MDR Report Key12188144
MDR Text Key262193958
Report Number2521402-2021-00049
Device Sequence Number1
Product Code FJK
UDI-Device Identifier04046964367786
UDI-Public(01)04046964367786
Combination Product (y/n)N
PMA/PMN Number
K080807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/23/2021
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 Expiration Date03/02/2024
Device Model NumberSL-2010M2096
Device Catalogue NumberSL-2010M2096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Initial Date Manufacturer Received 07/09/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received07/09/2021
Supplement Dates FDA Received08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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