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

Catalog Number	363421
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
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: brief inquiry description 1)particulate matter in drip chamber.2) secondary backing up into primary.Detailed inquiry description 1) rn when to prime tubing and saw brown dots in drip chamber.See pictures.2) secondary set backing up into primary.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photograph and two used samples were provided for evaluation.Upon visual inspection of the sample, one sample showed blackish foreign particles on the drip chamber.The other sample underwent piggyback testing, connected to an infusion pump operating for a fifteen-minute duration.Simultaneously, a secondary intravenous (iv) bag containing green dye was attached.This setup aimed to detect any backflow at the most distal backcheck valve.No signs of backflow were observed during the investigation.The photograph was evaluated, and black particles noted at the base of the drip chamber.Based on the data from the investigation, the reported defect of foreign matter was confirmed.The reported defect of backflow was unable to be confirmed.An investigation by the supplier determined that the black particles in the drip chamber are degraded spots of pvc embedded in the soft pvc chamber.Due to the lack of traceability information, the supplier was unable to conduct any batch review or further investigation.An approved project is in place to further address issues with sets which are unable to prime and backflow during secondary infusion with iv sets.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, INTRA
• 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; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19605139
• Report Number: 2523676-2024-00635
• Device Sequence Number: 12806523
• Product Code: FPA
• UDI-Device Identifier: 04046964294617
• UDI-Public: (01)04046964294617
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 363421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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