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

Catalog Number	354268
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description: cracked tubing/leaking.Detailed inquiry description: the tubing seemed to be cracked/leaking near the hub, thus having blood leak out onto the tubing, patient and nurse.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) contaminated sample was provided for evaluation.Visual evaluation along with comparison against the product technical drawing was conducted, and the set was observed to be assembled within internal specifications.Thereafter, the set underwent functional leakage testing, and leakage was present between the female luer lock adapter and the tubing.Based on the investigation finding, the sample was not within internal specification; therefore, the reported defect was confirmed.Incidents of this nature are attributed to operator oversight during the bonding process.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.A historical review of the customer complaint database dating back one year revealed no trends of this nature against this finished good item or lot number.Therefore, no formal corrective action is warranted at this time.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: 22457201
• Report Number: 2521402-2025-00220
• Device Sequence Number: 8218122
• Product Code: FPA
• UDI-Device Identifier: 04046955773022
• UDI-Public: (01)04046955773022(11)240627(17)290627(10)0061950794
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 354268
• Device Lot Number: 0061950794
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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