MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE MICRO¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	354269
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(6).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: patient arrived to er for liver lesion biopsy with conscious sedation.Patient's iv was flushed and connected to saline line prior to procedure and prepped as usual.During procedure rn noticed that patient was not illiciting normal response to fentanyl and versed that had been administered, by that time, the patient had received 125 mcg of fentanyl and 2.5 mg of versed.At that point, i had the provider pause what they were doing and had a look under the drape to inspect the iv to make sure it hadn't blown.At this point i saw a pool of blood-tinged saline covered patient's arm and blanket.The iv extension had been completely disconnected from microclave 1 way valve and the meds were being infused outside of the patient.At this point i cleansed the hub of the iv catheter and reconnected the line to the patient's iv.Patient then was administered 50 mcg of fentanyl and 1 mg of versed and patient fell into a moderate sedation.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be 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.The retained units were evaluated and passed the internal testing.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: CARESITE MICRO¿
• 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: 23025349
• Report Number: 2521402-2025-00820
• Device Sequence Number: 9427791
• Product Code: FPA
• UDI-Device Identifier: 04046955773183
• UDI-Public: (01)04046955773183(11)240823(17)270823(10)0061957470
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• 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): 10/23/2025

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: 354269
• Device Lot Number: 0061957470
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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 Sex: Unknown