MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	V1921
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No physical sample was returned for evaluation.The defect cannot be confirmed due to not having any evidence to support the reported incident.Please note: the medwatch received for this specific event indicates that the secondary medication may have rapidly infused or free flowed.Based on the known issue of pump set backflow impacting bbmi infusion lines ((b)(6) - 5/23/24-002-c, res# (b)(4)), it is likely an occurrence of backflow from the secondary medication bag to the primary bag was actually misinterpreted as free flow.However, additional information has not been received for this event at this time; and therefore, a medical device report for product problem is being submitted for free flow out of an abundance of caution.Note: the original initial mdr for this case was inadvertently submitted via the "test" account of the fda electronic submission gateway (esg) webtrader.As the original submission was not submitted through the "production" account of the fda esg webtrader, a new initial mdr submission is required per zoom call with (b)(6) of the fda esg help desk.
Event or Problem Description
As reported, hospital is seeing device issues when using either the b.Braun infusomat space pump iv set (ref: (b)(4)) or the b.Braun secondary iv set (ref: (b)(4)).We are seeing the medications either backflow into the primary line or rapidly infuse.We believe that a check valve is not performing as intended in certain lots of these sets.In this event: 2g/50ml bag magnesium sulfate was being prepared and set up in iv pump.Primary rn noticed the rate at which the magnesium was dripping in chamber was at a very rapid rate, despite being programmed appropriately in braun iv pump.Pump was set up to run at 100ml/hr.Primary rn changed the pump and the issue did not resolve.Rn then changed the secondary tubing and magnesium bag and issue still did not resolve.Rn also set up basic infusion rate to drip at a very slow rate to evaluate if drip rate would change.Was set up 10ml/hr for 100ml bag in pump and drip was still the same rapid rate.Braun lots being use were ref: (b)(4), lot #: 0061929393 dated 01/31/2029.Secondary iv tubing was changed to a different lot # and the issue resolved and drip rate in chamber was at appropriate rate as programmed in pump.This lead to a delay in treatment for the patient.

• Brand Name: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km 22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20411678
• Report Number: 2523676-2024-00753
• Device Sequence Number: 7983404
• Product Code: FPA
• UDI-Device Identifier: 04046964188558
• UDI-Public: (01)04046964188558
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: V1921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White