MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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.

• 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 Key: 14999283
• MDR Text Key: 295776827
• Report Number: 14999283
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: SL-2010M2096
• Device Catalogue Number: SL-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 FDA: 06/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1