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

Catalog Number	480257
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/05/2024
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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.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, this rn to bedside to start etoposide chemotherapy.Prepared using correct ppe with circle proming technique with chemolocks, attached tubing to secondary port in primary set (also with chemolock).Second rn dakota to bedside to double check/sign chemo.This rn at the computer, (b)(6) rn checking information on bag and pump for settings.Upon pressing start button on pump, pump alarmed "air bubble", so dakota rn tried to open air filter on chamber of secondary set to resolve issue.Entire filter, not just door, popped off chamber, and chemo was spraying directly out of said port.(b)(6) rn did not have gloves on, see other workforce safety e-feedback.This rn grabbed tubing with gloves on, folded tubing in to clamp/pressed finger onto tubing to prevent further leaking.Dakota rn washed hands throughly immediately and went to ask sara charge rn to bring in hemostats to clamp tubing further.Area cleaned.Tubing and bag of chemo placed back in hazard bag.New bag of etop requested up from pharmacy to prep as soon as possible.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photograph of the incident was submitted for evaluation.Upon evaluation, it was noticed that the air vent was absent from the drip chamber.Although the reported defect was confirmed, a thorough investigation could not be performed without the actual sample.The defective device is valuable tool in investigating the cause of this incident.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• 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
• MDR Report Key: 20395503
• Report Number: 2523676-2024-00720
• Device Sequence Number: 6566891
• Product Code: FPA
• UDI-Device Identifier: 04046955324828
• UDI-Public: (01)04046955324828
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 480257
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown