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

Catalog Number	415400
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description: chemo leaked from extension set onto patient.Detailed inquiry description: patients extension set separated from the piv and blood and chemo leaked onto patient.Patient had docetaxel chemotherapy infusing when the cap on the iv catheter became disconnected from the extension tubing on the patient's piv.Patient's piv then back flowed blood all over the patient, the infusion chair, and the floor.The chemotherapy that was infusing when the cap became detached, leaked onto the patient's skin, the infusion chair, and the floor.Patient put on her call light when she noticed her iv was bleeding.When writer walked in the room, immediately clamped patient's piv to stop it from further bleeding and stopped the patient's infusion pump to stop further chemotherapy from leaking all over.Chemo spill kit was then obtained, and the chemotherapy was cleaned up per protocol.Cleaned up the blood on the patient, chair, and floor, and washed patient's arm with soapy wipes where the chemotherapy came into contact with her skin.Offered patient hospital gown and pants to wear.After chemo and blood clean up.Infusion was restarted with no further issue.Instructed patient to monitor her skin for any adverse reactions and let triage know if she develops any issues.
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) photo was submitted to the manufacturer for evaluation.Through visual examination of the photo, the photo was noted to be of the packaging that showed the item number, expiration date and lot number information.The actual complaint product was not observed in the photo.The reported defect could not be observed from the photo.Retained samples with the same lot number were visually inspected.Additionally, a lure taper test was also conducted, with the results indicating that five out of five samples were found acceptable with passing results.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.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21961466
• Report Number: 2523676-2025-00427
• Device Sequence Number: 9274280
• Product Code: FPA
• UDI-Device Identifier: 04046955781881
• UDI-Public: (01)04046955781881(11)240603(17)290603(10)0061945144
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212842
• 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): 06/30/2025

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: 415400
• Device Lot Number: 0061945144
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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