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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 AND WITHOUT ANTI-REGURGITATION VALVE

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B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number SL-2010M2096
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 06/27/2022
Event Type  malfunction  
Event Description
B braun streamline airless system set with defective venous line.Tubing below venous chamber with visible crack.Ref # (b)(4), lot # 20354001, expiration date 2025-03-01.All streamline line boxes checked for lot # but no other ones found.Manufacturer response for set, tubing, blood, with and without anti-regurgitation valve, hemodialysis bloodlines (per site reporter).Hospital staff made contact with the local representative, and the individual directed us to contact b braun's clinical team.Hospital staff have sent pictures of the failed devices.Investigation is in progress.More product was ordered in with a different lot number.
 
Event Description
B braun streamline airless system set with defective venous line.Tubing below venous chamber with visible crack.Ref # sl-2010m2096, lot # 20354001, expiration date 2025-03-01.All streamline line boxes checked for lot # but no other ones found.Manufacturer response for set, tubing, blood, with and without anti-regurgitation valve, hemodialysis bloodlines (per site reporter) hospital staff made contact with the local representative, and the individual directed us to contact b braun's clinical team.Hospital staff have sent pictures of the failed devices.Investigation is in progress.More product was ordered in with a different lot number.
 
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Brand Name
HEMODIALYSIS BLOODLINES
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 twelfth avenue
bethlehem PA 18018
MDR Report Key14999283
MDR Text Key295776827
Report Number14999283
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2022
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 Model NumberSL-2010M2096
Device Catalogue NumberSL-2010M2096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2022
Event Location Hospital
Date Report to Manufacturer07/13/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/13/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/21/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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