MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ADDITIV®; SET, ADMINISTRATION, INTRA

Catalog Number	V1447
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: details of complaint (reported issue): backflow of the pts blood was in the iv line.Upon observation there was a hole in the line between the ports which caused blood to leak on the floor and spray on our treadmill case system.How was it detected? a hole in the iv tubing causing blood to leak.Describe reported problem/event in detail: (use another sheet if necessary) tubing was attached to patient and flushed.Hub was connected for persantine infusion.Tech then stepped away from patient to review paperwork with physician.Upon return to the room, there was spill of blood along the procedure room floor and equipment.Test was completed and the patient was removed from the area and room was wiped.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Due to unforeseen issues during the receiving of the samples, it has been determined that the sample was inadvertently misplaced and unable to be located.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: ADDITIV®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19212962
• Report Number: 2523676-2024-00416
• Device Sequence Number: 12498070
• Product Code: FPA
• UDI-Device Identifier: 04046964188411
• UDI-Public: (01)04046964188411
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: V1447
• Device Lot Number: 0061885290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• 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