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
Event or Problem Description
As reported by the user facility: upon rounding the nursing units, two issues were at play.One was improper use of the spin lock - education was provided but there was not always a connection formed by exposing the male luer tip then locking on.This led to connections that were not tight or did not fully open their blood control septum creating challenges in rad.Education provided.The other and more frequent concern was a loose caresite micro out of the package.The product would look secure, and some clinicians did not tighten on - they reported numerous instances of returning to patient rooms to find fluid, meds, or blood all over from the caresite micro falling off.Education was provided to always ensure tight connection but request from customer to have come out of package tighter.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

• 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: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50867033
• Report Number: 2521402-2026-00858
• Device Sequence Number: 21138209
• Product Code: FPA
• UDI-Device Identifier: 04046955773183
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 0062040001
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2025
• 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