MAUDE Adverse Event Report: B. BRAUN B. BRAUN IV TUBING; SET, I.V. FLUID TRANSFER

Device Problems Defective Device (2588); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

We have had 3 issues recently with the b braun tubing and i had reached out to (b)(4) at b.Braun about them i had made follow up e-mails and calls about them on 2/27/2023.On (b)(6): received an e-mail from (b)(4) that they received the samples on (b)(6) but the investigation was still in process.On (b)(6): received a phone call from (b)(4) that they had 3 items pir # (b)(4) and her # is (b)(4) i have had 3 sets of tubing that i have had to replace before mixing because i could pull the coupler could be pulled back further then it should making the connection unsecure.With the 3 primary sets where the tubing came apart at the blue y-site, 1 was an imfinzi dose and the other 2 where flush bags.I also have a defective primary tubing from another flush bag in my office as well as a defective bag of 0.9% sodium chloride 250 mls (20 mls in the bag sealed in the plastic overwrap).Let me know if you want photos of the tubing and the packaging for this flush bag.Also feel free to reach out to me with any other questions you may have.Previous issue with b.Braun pump tubing and bd connector to closed system.Reference report: mw5115799, mw5115802, mw5115803.

• Brand Name: B. BRAUN IV TUBING
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 16571942
• MDR Text Key: 311595075
• Report Number: MW5115801
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SODIUM CHLORIDE
• Patient Outcome(s): Other