MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; CONNECTOR (C35-O)

Catalog Number	515070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Event details: during infusion of high-dose melphalan, a minor leak occurs in the connection between the drip tube and connector.The patient receives an estimated one milliliter of chemotherapy on the right upper arm and one milliliter on the sheet.The drip is stopped.The skin is washed abundantly with soap and water and the sheets are changed.After switching with a new connector, melphalanet can be restarted without remark no obvious irritation is noted on the skin.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2508501.No deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification, such as the luer threading.Results were reviewed for the reported lot and no issues related to the reported event were found.Retained samples of lot 2508501 were used for additional evaluation.All products were visually inspected, and no damage or other defects were observed.Dimensional testing was completed, and all product was verified to meet required specification.Based on the quality team's investigation, including retained sample analysis and device history review, no product- or process-related issues were identified; therefore, a root cause could not be determined at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
Additional information: dchu met with reps to clarify event details as email responses were conflicting to what was reported.Based on provided information, there was a leakage at the luer connection of the connector and mating tubing.Mating tubing does not belong to bd.There was no clear evidence of a disconnection at the time of the incident, however, upon reviewing the event details with the customer, it is believed they were not using the proper techniques when connecting the devices.Reps went on site and performed additional training to ensure they are fulling connecting the devices.There was not impact to the patient or healthcare professional.There is only one connector lot at this facility, 2508501.No samples available at this time.

• Brand Name: BD PHASEAL OPTIMA
• Common Device Name: CONNECTOR (C35-O)
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24007894
• Report Number: 3003152976-2025-00720
• Device Sequence Number: 18449727
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• UDI-Public: (01)00382905150562(11)250414(17)270930(10)2504801
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 515070
• Device Lot Number: 2508501
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown