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

Catalog Number	490105
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/21/2025
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: during therapy rn primed 490105 with saline and blood, loaded pump and started infusion.Not longer after patient said that blood was leaking.Rn looked for leak and said the blood was leaking from under the iv pump and started dripping on the floor.When rn went to take out tubing, the tubing separated on the left side of the line loading guide.Blood splattered everywhere (inside and outside the pump) causing delay in infusion.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400732622.Six photographs and one used sample without packaging were provided for investigation.Upon evaluation of the images, two photos visualized the pump with blood residue.The remaining images displayed the sample label and the pump with tubing detached from the space pump.The sample was observed to be used, contaminated with blood, and detached.The reported issue was confirmed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Incidents of this nature are attributed to operator oversight during the manual solvent application process of the product.The operator applied insufficient solvent on the tubing during the bonding process.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.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23478278
• Report Number: 2521402-2025-01348
• Device Sequence Number: 10228739
• Product Code: FPA
• UDI-Device Identifier: 04046964186165
• UDI-Public: (01)04046964186165(11)250626(17)280531(10)0062016906
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 490105
• Device Lot Number: 0062016906
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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